Regulatory Open Forum

​Hi Laura.

In your case (and I have not done devices in a while so this may be different now!) I would think that purely cosmetic marketing claims such as improved visibility, shadow minimizing, etc. would likely be regulated as a non-device.  However, I am not sure why you would make such a device with these claims.  When I think of things inserted into the body or body cavities, I generally think either diagnostic or treatment which again would place your product into a device classification.  Since there is no current predicate (although I wonder if you could use a combination of predicates in this case) you likely will need to go de novo or PMA. 

Remember - in FDA's world - almost every instance of question resolves by claims.  It's all about the claims you as the manufacturer make on the device.  Even some product code decisions are driven by the exact claims made.  Hope some of this helps and isn't too far off reality in this area!

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Original Message------

​Hi Laura.

In your case (and I have not done devices in a while so this may be different now!) I would think that purely cosmetic marketing claims such as improved visibility, shadow minimizing, etc. would likely be regulated as a non-device.  However, I am not sure why you would make such a device with these claims.  When I think of things inserted into the body or body cavities, I generally think either diagnostic or treatment which again would place your product into a device classification.  Since there is no current predicate (although I wonder if you could use a combination of predicates in this case) you likely will need to go de novo or PMA. 

Remember - in FDA's world - almost every instance of question resolves by claims.  It's all about the claims you as the manufacturer make on the device.  Even some product code decisions are driven by the exact claims made.  Hope some of this helps and isn't too far off reality in this area!

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
------------------------------

Hi Laura,
I think Victor put it very succinctly. My recommendation is to start with the intended use i.e. where and how do you, as the manufacturer, want the device to be utilized. Then take the perspective of a user/clinician and ask what clinical utility it provides. For example, does the clinician use this device purely as an illumination source.
Also, few points about illumination sources:
- consult the past few years of FDA notice on devices (product codes in particular) that are exempt from 510(k) review. This does not change their device class but at least removed the FDA review burden.
- while other light sources, such as Xenon, are still regulated as Class-II devices, LEDs tend to enjoy a lower risk classification.
- if your LED is a laser source then keep in mind that FDA also regulates devices with lasers in them. This is completely separate from the medical device regulations. So you will have to look into laser source regulations and medical device regulations if you are contemplating clinical claims. Double the fun!

Hope this helps.

Cheers
Thas 

------------------------------
Thas Yuwaraj
Synaptive Medical
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Thank you both Victor and Thas for the very detailed response.  The company is refusing to go the De Novo route and has decided that they would like to use one of their predicate devices for the medical claims and promote this one as a new and improved one that has the same intended use as the current device, except it has LED, and physically looks very different, will improve appearance of or will rejuvenate the woman's private part.  They want to remain purely cosmetic with this new device and make no new medical claims.  I wonder too, if we could use two predicates since the device they are proposing differs in technological aspects i.e. light source etc.  There are a few LED devices out there for wrinkles, different anatomic site though...There is also a heat aspect of the device, and I wondered if that also would categorize it as a regulated device.  I have always dealt with dental implants so these devices are way different, and I am trying to navigate through this. 

Fun fun, fun!


Thank you,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Hi Laura,

A reminder that of late FDA would prefer one predicate vs additional ones so if you have to use more than one predicate work with someone that is up on the regulations and has done many 510(k)s.  

The other thing I wanted to point out is there is a slew of standards that probably apply such as IEC 60825-1 (for LEDs - Lasers), IEC 60601-1, IEC 60601-1-2, and if home use which sounds likely then IEC 60601-1-11, IEC 60601-1-6 and the FDA Guidance for Home Use Devices, which would then also bring up other electrical based guidances as well.

All the best,

------------------------------
Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 21-Jul-2017 11:50
From: LAURA HOSHUE
Subject: LED devices

Thank you both Victor and Thas for the very detailed response.  The company is refusing to go the De Novo route and has decided that they would like to use one of their predicate devices for the medical claims and promote this one as a new and improved one that has the same intended use as the current device, except it has LED, and physically looks very different, will improve appearance of or will rejuvenate the woman's private part.  They want to remain purely cosmetic with this new device and make no new medical claims.  I wonder too, if we could use two predicates since the device they are proposing differs in technological aspects i.e. light source etc.  There are a few LED devices out there for wrinkles, different anatomic site though...There is also a heat aspect of the device, and I wondered if that also would categorize it as a regulated device.  I have always dealt with dental implants so these devices are way different, and I am trying to navigate through this. 

Fun fun, fun!


Thank you,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Thank you so much Leonard.  It is quite challenging because I have proposed the de novo process and have warned that using their own device as the predicate, while claims are the same, but significantly technologically different, could result in an NSE.  How do I deal with such resistance?


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 21-Jul-2017 12:23
From: Leonard Eisner
Subject: LED devices

Hi Laura,

A reminder that of late FDA would prefer one predicate vs additional ones so if you have to use more than one predicate work with someone that is up on the regulations and has done many 510(k)s.  

The other thing I wanted to point out is there is a slew of standards that probably apply such as IEC 60825-1 (for LEDs - Lasers), IEC 60601-1, IEC 60601-1-2, and if home use which sounds likely then IEC 60601-1-11, IEC 60601-1-6 and the FDA Guidance for Home Use Devices, which would then also bring up other electrical based guidances as well.

All the best,

------------------------------
Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 21-Jul-2017 11:50
From: LAURA HOSHUE
Subject: LED devices

Thank you both Victor and Thas for the very detailed response.  The company is refusing to go the De Novo route and has decided that they would like to use one of their predicate devices for the medical claims and promote this one as a new and improved one that has the same intended use as the current device, except it has LED, and physically looks very different, will improve appearance of or will rejuvenate the woman's private part.  They want to remain purely cosmetic with this new device and make no new medical claims.  I wonder too, if we could use two predicates since the device they are proposing differs in technological aspects i.e. light source etc.  There are a few LED devices out there for wrinkles, different anatomic site though...There is also a heat aspect of the device, and I wondered if that also would categorize it as a regulated device.  I have always dealt with dental implants so these devices are way different, and I am trying to navigate through this. 

Fun fun, fun!


Thank you,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

​​There is a time-honored "Plan C" that RA professionals must sometimes fall back on:

"OK, fine, if that's what you want, I will send it to FDA and let them tell you that they aren't going to accept it."

If you are lucky, they won't even get an NSE. Instead, FDA may simply RTA it and save your company (and itself) a lot of wasted time and effort.  Not that it's likely to thank FDA for doing it this favor.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Jul-2017 12:51
From: LAURA HOSHUE
Subject: LED devices

Thank you so much Leonard.  It is quite challenging because I have proposed the de novo process and have warned that using their own device as the predicate, while claims are the same, but significantly technologically different, could result in an NSE.  How do I deal with such resistance?


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 21-Jul-2017 12:23
From: Leonard Eisner
Subject: LED devices

Hi Laura,

A reminder that of late FDA would prefer one predicate vs additional ones so if you have to use more than one predicate work with someone that is up on the regulations and has done many 510(k)s.  

The other thing I wanted to point out is there is a slew of standards that probably apply such as IEC 60825-1 (for LEDs - Lasers), IEC 60601-1, IEC 60601-1-2, and if home use which sounds likely then IEC 60601-1-11, IEC 60601-1-6 and the FDA Guidance for Home Use Devices, which would then also bring up other electrical based guidances as well.

All the best,

------------------------------
Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 21-Jul-2017 11:50
From: LAURA HOSHUE
Subject: LED devices

Thank you both Victor and Thas for the very detailed response.  The company is refusing to go the De Novo route and has decided that they would like to use one of their predicate devices for the medical claims and promote this one as a new and improved one that has the same intended use as the current device, except it has LED, and physically looks very different, will improve appearance of or will rejuvenate the woman's private part.  They want to remain purely cosmetic with this new device and make no new medical claims.  I wonder too, if we could use two predicates since the device they are proposing differs in technological aspects i.e. light source etc.  There are a few LED devices out there for wrinkles, different anatomic site though...There is also a heat aspect of the device, and I wondered if that also would categorize it as a regulated device.  I have always dealt with dental implants so these devices are way different, and I am trying to navigate through this. 

Fun fun, fun!


Thank you,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

​Nothing about the technology classifies a device as a regulated device, only the intended use.

I agree with your assessment that the technology may determine whether or not FDA will accept it as SE to a predicate with the same intended use.  The technology may also have an impact on its risk classification.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Jul-2017 11:50
From: LAURA HOSHUE
Subject: LED devices

Thank you both Victor and Thas for the very detailed response.  The company is refusing to go the De Novo route and has decided that they would like to use one of their predicate devices for the medical claims and promote this one as a new and improved one that has the same intended use as the current device, except it has LED, and physically looks very different, will improve appearance of or will rejuvenate the woman's private part.  They want to remain purely cosmetic with this new device and make no new medical claims.  I wonder too, if we could use two predicates since the device they are proposing differs in technological aspects i.e. light source etc.  There are a few LED devices out there for wrinkles, different anatomic site though...There is also a heat aspect of the device, and I wondered if that also would categorize it as a regulated device.  I have always dealt with dental implants so these devices are way different, and I am trying to navigate through this. 

Fun fun, fun!


Thank you,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Agreed Julie.  Great feedback as always.  Much appreciated.



Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 21-Jul-2017 17:32
From: Julie Omohundro
Subject: LED devices

​Nothing about the technology classifies a device as a regulated device, only the intended use.

I agree with your assessment that the technology may determine whether or not FDA will accept it as SE to a predicate with the same intended use.  The technology may also have an impact on its risk classification.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Jul-2017 11:50
From: LAURA HOSHUE
Subject: LED devices

Thank you both Victor and Thas for the very detailed response.  The company is refusing to go the De Novo route and has decided that they would like to use one of their predicate devices for the medical claims and promote this one as a new and improved one that has the same intended use as the current device, except it has LED, and physically looks very different, will improve appearance of or will rejuvenate the woman's private part.  They want to remain purely cosmetic with this new device and make no new medical claims.  I wonder too, if we could use two predicates since the device they are proposing differs in technological aspects i.e. light source etc.  There are a few LED devices out there for wrinkles, different anatomic site though...There is also a heat aspect of the device, and I wondered if that also would categorize it as a regulated device.  I have always dealt with dental implants so these devices are way different, and I am trying to navigate through this. 

Fun fun, fun!


Thank you,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

This appears to be one of the products that are not "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" but fit the definition because they are "intended to affect the structure or any function of the body."

The FDA will grant the De novo petition if the company provides evidence that its benefits outweigh its risks, and that its level of risk does not warrant regulation as a Class III device.  The problem with a "cosmetic only" claim is that the benefits tend to be considered minimal compared to those that would be associated with a medical claim, which means there is not much there to offset any risks.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 22-Jul-2017 10:20
From: Glen Emelock
Subject: LED devices

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Thank you Julie.  That is exactly what I have been telling the team.  Thank you for providing such great feedback always.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 22-Jul-2017 14:04
From: Julie Omohundro
Subject: LED devices

This appears to be one of the products that are not "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" but fit the definition because they are "intended to affect the structure or any function of the body."

The FDA will grant the De novo petition if the company provides evidence that its benefits outweigh its risks, and that its level of risk does not warrant regulation as a Class III device.  The problem with a "cosmetic only" claim is that the benefits tend to be considered minimal compared to those that would be associated with a medical claim, which means there is not much there to offset any risks.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 22-Jul-2017 10:20
From: Glen Emelock
Subject: LED devices

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Julie,

Thanks again.  What then do you recommend in my case? There is no currently marketed/cleared device from which we can claim SE and the one that they are requesting we use as the predicate, while similar in the medical claims i.e. kegels, floor strengthening etc., has very different physical characteristics, new material on the outer part that has patient contact, heat and LED elements.


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 22-Jul-2017 14:04
From: Julie Omohundro
Subject: LED devices

This appears to be one of the products that are not "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" but fit the definition because they are "intended to affect the structure or any function of the body."

The FDA will grant the De novo petition if the company provides evidence that its benefits outweigh its risks, and that its level of risk does not warrant regulation as a Class III device.  The problem with a "cosmetic only" claim is that the benefits tend to be considered minimal compared to those that would be associated with a medical claim, which means there is not much there to offset any risks.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 22-Jul-2017 10:20
From: Glen Emelock
Subject: LED devices

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Julie,

Thanks again.  What then do you recommend in my case? There is no currently marketed/cleared device from which we can claim SE and the one that they are requesting we use as the predicate, while similar in the medical claims i.e. kegels, floor strengthening etc., has very different physical characteristics, new material on the outer part that has patient contact, heat and LED elements.


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 22-Jul-2017 14:04
From: Julie Omohundro
Subject: LED devices

This appears to be one of the products that are not "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" but fit the definition because they are "intended to affect the structure or any function of the body."

The FDA will grant the De novo petition if the company provides evidence that its benefits outweigh its risks, and that its level of risk does not warrant regulation as a Class III device.  The problem with a "cosmetic only" claim is that the benefits tend to be considered minimal compared to those that would be associated with a medical claim, which means there is not much there to offset any risks.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 22-Jul-2017 10:20
From: Glen Emelock
Subject: LED devices

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

​I would document my concerns and that you shared your concern with the team.  (An email to the key players summarizing your concerns is fine.) 

Then go ahead and submit the 510(k).  At some point, the sooner you submit it, the sooner it can be RTA'd or NSE'd and everyone can move on.  Or, who knows, maybe the FDA will accept it as SE.  When it comes to FDA, I never say never.

You could also consider a 513(g) or a pre-sub, but those might just drag things out to no avail.  Plus, I'm starting to get the idea that maybe your management doesn't really want to know...

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 24-Jul-2017 15:56
From: LAURA HOSHUE
Subject: LED devices

Julie,

Thanks again.  What then do you recommend in my case? There is no currently marketed/cleared device from which we can claim SE and the one that they are requesting we use as the predicate, while similar in the medical claims i.e. kegels, floor strengthening etc., has very different physical characteristics, new material on the outer part that has patient contact, heat and LED elements.


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 22-Jul-2017 14:04
From: Julie Omohundro
Subject: LED devices

This appears to be one of the products that are not "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" but fit the definition because they are "intended to affect the structure or any function of the body."

The FDA will grant the De novo petition if the company provides evidence that its benefits outweigh its risks, and that its level of risk does not warrant regulation as a Class III device.  The problem with a "cosmetic only" claim is that the benefits tend to be considered minimal compared to those that would be associated with a medical claim, which means there is not much there to offset any risks.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 22-Jul-2017 10:20
From: Glen Emelock
Subject: LED devices

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Often management doesn't listen to their own people.  I sensed in some of the dialog that you are looking for "backup" within the group, some perspective, etc.  Another option might be to go thru the 513(g) process for a device classification assessment.  What do people think of such an approach?

------------------------------
Rick Muller RAC
Technical Director
Celestica Healthcare
Aurora CO
United States
------------------------------

Original Message:
Sent: 24-Jul-2017 20:05
From: Julie Omohundro
Subject: LED devices

​I would document my concerns and that you shared your concern with the team.  (An email to the key players summarizing your concerns is fine.) 

Then go ahead and submit the 510(k).  At some point, the sooner you submit it, the sooner it can be RTA'd or NSE'd and everyone can move on.  Or, who knows, maybe the FDA will accept it as SE.  When it comes to FDA, I never say never.

You could also consider a 513(g) or a pre-sub, but those might just drag things out to no avail.  Plus, I'm starting to get the idea that maybe your management doesn't really want to know...

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 24-Jul-2017 15:56
From: LAURA HOSHUE
Subject: LED devices

Julie,

Thanks again.  What then do you recommend in my case? There is no currently marketed/cleared device from which we can claim SE and the one that they are requesting we use as the predicate, while similar in the medical claims i.e. kegels, floor strengthening etc., has very different physical characteristics, new material on the outer part that has patient contact, heat and LED elements.


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 22-Jul-2017 14:04
From: Julie Omohundro
Subject: LED devices

This appears to be one of the products that are not "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" but fit the definition because they are "intended to affect the structure or any function of the body."

The FDA will grant the De novo petition if the company provides evidence that its benefits outweigh its risks, and that its level of risk does not warrant regulation as a Class III device.  The problem with a "cosmetic only" claim is that the benefits tend to be considered minimal compared to those that would be associated with a medical claim, which means there is not much there to offset any risks.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 22-Jul-2017 10:20
From: Glen Emelock
Subject: LED devices

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

All I can say is that over a decade ago, we had a minimally invasive product for vaginal "tightening" that sounds similar (though it used a different heating mechanism than LED). Not only was the idea that it was "cosmetic" not accepted, but at that time, FDA was going down a PMA type pathway with it. As you point out, the devices you listed are really not predicates, either in technology or mechanism of action. I suspect we could have eventually gotten to a De Novo, but we chose not to pursue (those were different times)

I'd suggest a "pre-sub" meeting to sort this out, but if management really doesn't want to go there, it is probably best to just submit the 510(k) and get the NSE. Make sure they, not you, sign the 510(k).

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 24-Jul-2017 15:56
From: LAURA HOSHUE
Subject: LED devices

Julie,

Thanks again.  What then do you recommend in my case? There is no currently marketed/cleared device from which we can claim SE and the one that they are requesting we use as the predicate, while similar in the medical claims i.e. kegels, floor strengthening etc., has very different physical characteristics, new material on the outer part that has patient contact, heat and LED elements.


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 22-Jul-2017 14:04
From: Julie Omohundro
Subject: LED devices

This appears to be one of the products that are not "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" but fit the definition because they are "intended to affect the structure or any function of the body."

The FDA will grant the De novo petition if the company provides evidence that its benefits outweigh its risks, and that its level of risk does not warrant regulation as a Class III device.  The problem with a "cosmetic only" claim is that the benefits tend to be considered minimal compared to those that would be associated with a medical claim, which means there is not much there to offset any risks.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 22-Jul-2017 10:20
From: Glen Emelock
Subject: LED devices

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Thank you Ginger. Now we are making it even more complicated by adding a temperature sensor that will read vaginal moisture etc.  Does that mean that we have to file in a different category? Can the device be all encompassing of multiple product codes? I am really trying here and it can be quite frustrating because Marketing is trying hard to push the limits.


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 25-Jul-2017 08:42
From: Ginger Glaser
Subject: LED devices

All I can say is that over a decade ago, we had a minimally invasive product for vaginal "tightening" that sounds similar (though it used a different heating mechanism than LED). Not only was the idea that it was "cosmetic" not accepted, but at that time, FDA was going down a PMA type pathway with it. As you point out, the devices you listed are really not predicates, either in technology or mechanism of action. I suspect we could have eventually gotten to a De Novo, but we chose not to pursue (those were different times)

I'd suggest a "pre-sub" meeting to sort this out, but if management really doesn't want to go there, it is probably best to just submit the 510(k) and get the NSE. Make sure they, not you, sign the 510(k).

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States

Original Message:
Sent: 24-Jul-2017 15:56
From: LAURA HOSHUE
Subject: LED devices

Julie,

Thanks again.  What then do you recommend in my case? There is no currently marketed/cleared device from which we can claim SE and the one that they are requesting we use as the predicate, while similar in the medical claims i.e. kegels, floor strengthening etc., has very different physical characteristics, new material on the outer part that has patient contact, heat and LED elements.


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA

Original Message:
Sent: 22-Jul-2017 14:04
From: Julie Omohundro
Subject: LED devices

This appears to be one of the products that are not "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" but fit the definition because they are "intended to affect the structure or any function of the body."

The FDA will grant the De novo petition if the company provides evidence that its benefits outweigh its risks, and that its level of risk does not warrant regulation as a Class III device.  The problem with a "cosmetic only" claim is that the benefits tend to be considered minimal compared to those that would be associated with a medical claim, which means there is not much there to offset any risks.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 22-Jul-2017 10:20
From: Glen Emelock
Subject: LED devices

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

1) yes, a temperature sensor "reading" moisture will likely change your approach. It could easily be deemed a "significant technology change" from your predicate, just for instance

2) You can use multiple product codes for a single device, and to some extent multiple predicates. For instance, if an MRI coil is also sold with a head fixation system. That said, int his case, I'd expect some pushback from FDA, quite honestly - it still seems to me that the product you describe will in the end require a De Novo.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Engineering
(formerly VP, RA/QA)
Monteris Medical
MN
------------------------------

Original Message:
Sent: 09-Aug-2017 15:20
From: LAURA HOSHUE
Subject: LED devices

Thank you Ginger. Now we are making it even more complicated by adding a temperature sensor that will read vaginal moisture etc.  Does that mean that we have to file in a different category? Can the device be all encompassing of multiple product codes? I am really trying here and it can be quite frustrating because Marketing is trying hard to push the limits.


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA

Original Message:
Sent: 25-Jul-2017 08:42
From: Ginger Glaser
Subject: LED devices

All I can say is that over a decade ago, we had a minimally invasive product for vaginal "tightening" that sounds similar (though it used a different heating mechanism than LED). Not only was the idea that it was "cosmetic" not accepted, but at that time, FDA was going down a PMA type pathway with it. As you point out, the devices you listed are really not predicates, either in technology or mechanism of action. I suspect we could have eventually gotten to a De Novo, but we chose not to pursue (those were different times)

I'd suggest a "pre-sub" meeting to sort this out, but if management really doesn't want to go there, it is probably best to just submit the 510(k) and get the NSE. Make sure they, not you, sign the 510(k).

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States

Original Message:
Sent: 24-Jul-2017 15:56
From: LAURA HOSHUE
Subject: LED devices

Julie,

Thanks again.  What then do you recommend in my case? There is no currently marketed/cleared device from which we can claim SE and the one that they are requesting we use as the predicate, while similar in the medical claims i.e. kegels, floor strengthening etc., has very different physical characteristics, new material on the outer part that has patient contact, heat and LED elements.


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA

Original Message:
Sent: 22-Jul-2017 14:04
From: Julie Omohundro
Subject: LED devices

This appears to be one of the products that are not "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" but fit the definition because they are "intended to affect the structure or any function of the body."

The FDA will grant the De novo petition if the company provides evidence that its benefits outweigh its risks, and that its level of risk does not warrant regulation as a Class III device.  The problem with a "cosmetic only" claim is that the benefits tend to be considered minimal compared to those that would be associated with a medical claim, which means there is not much there to offset any risks.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 22-Jul-2017 10:20
From: Glen Emelock
Subject: LED devices

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Again Ginger, thank you for the information.  As someone coming from dental implants to these new devices, the experience, while I welcome the learning and wealth of information I have acquired thus far, has been nothing short of frustrating and challenging.  

I have not seen a product code for the temperature sensors, but will look again.  


I will certainly keep you guys updated on where this ends up ultimately.


Thanks,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 11-Aug-2017 08:56
From: Ginger Glaser
Subject: LED devices

1) yes, a temperature sensor "reading" moisture will likely change your approach. It could easily be deemed a "significant technology change" from your predicate, just for instance

2) You can use multiple product codes for a single device, and to some extent multiple predicates. For instance, if an MRI coil is also sold with a head fixation system. That said, int his case, I'd expect some pushback from FDA, quite honestly - it still seems to me that the product you describe will in the end require a De Novo.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Engineering
(formerly VP, RA/QA)
Monteris Medical
MN

Original Message:
Sent: 09-Aug-2017 15:20
From: LAURA HOSHUE
Subject: LED devices

Thank you Ginger. Now we are making it even more complicated by adding a temperature sensor that will read vaginal moisture etc.  Does that mean that we have to file in a different category? Can the device be all encompassing of multiple product codes? I am really trying here and it can be quite frustrating because Marketing is trying hard to push the limits.


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA

Original Message:
Sent: 25-Jul-2017 08:42
From: Ginger Glaser
Subject: LED devices

All I can say is that over a decade ago, we had a minimally invasive product for vaginal "tightening" that sounds similar (though it used a different heating mechanism than LED). Not only was the idea that it was "cosmetic" not accepted, but at that time, FDA was going down a PMA type pathway with it. As you point out, the devices you listed are really not predicates, either in technology or mechanism of action. I suspect we could have eventually gotten to a De Novo, but we chose not to pursue (those were different times)

I'd suggest a "pre-sub" meeting to sort this out, but if management really doesn't want to go there, it is probably best to just submit the 510(k) and get the NSE. Make sure they, not you, sign the 510(k).

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States

Original Message:
Sent: 24-Jul-2017 15:56
From: LAURA HOSHUE
Subject: LED devices

Julie,

Thanks again.  What then do you recommend in my case? There is no currently marketed/cleared device from which we can claim SE and the one that they are requesting we use as the predicate, while similar in the medical claims i.e. kegels, floor strengthening etc., has very different physical characteristics, new material on the outer part that has patient contact, heat and LED elements.


Thank you.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA

Original Message:
Sent: 22-Jul-2017 14:04
From: Julie Omohundro
Subject: LED devices

This appears to be one of the products that are not "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" but fit the definition because they are "intended to affect the structure or any function of the body."

The FDA will grant the De novo petition if the company provides evidence that its benefits outweigh its risks, and that its level of risk does not warrant regulation as a Class III device.  The problem with a "cosmetic only" claim is that the benefits tend to be considered minimal compared to those that would be associated with a medical claim, which means there is not much there to offset any risks.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 22-Jul-2017 10:20
From: Glen Emelock
Subject: LED devices

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura

Thank you Glen.  This has been an ongoing battle since I came on board three months ago.  While my background is all dental implant devices, what I have read and researched so far, has led me to that same argument and conversations with upper management.  To use a device that is cleared for Kegel exercises as a predicate, and promote this one as a new an improved version of the predicate only that it comes with LED and heat elements, but more of a cosmetic intended use, is hard for me to justify.  That is the route though they are pushing for.  With no cleared OTC device with this feature, indicated for that anatomical site, it is a struggle.


Your feedback was quite enlightening.

Thank you!

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 22-Jul-2017 10:20
From: Glen Emelock
Subject: LED devices

​Hi Laura:

Several clarifications which may (or may not) be what senior management desired:

FDA has considered and regulated light based and heat producing products for aesthetic beauty purposes (ex. hair reduction, hair regrowth, wrinkle reduction, 'skin rejuvenation', etc.) even though these products do not meet the definition of a medical device (intended to diagnose or treat a disease) first as professional (MD) use always  and for OTC use ever since the mid 2000's.  My company and I have personally prepared dozens of 510(k)s for light/LED based products over the last decade.

Although we are familiar with pro use light based products for vaginal cosmetic / aesthetic use which have received 510(k) clearance, and whilst there are a number of LED/heat producing products for medical device OTC uses (ex. relieve knee osteoarthritis pain), I know of none so far with a OTC clearance for what may be considered vaginal tightening/aesthetic appearance improvement.

FDA historically does not treat companies marketing such products without clearance lightly, and even if you were to attempt deNovo, because of the LEDs and invasive contact, its unlikely FDA would grant this.  Furthermore, FDA would expect several clinical studies supporting whatever efficacy/performance claims are being made, in addition to safety and labeling comprehension and use for the OTC  clearance.

Happy to discuss  further hope this helps!

Glen




------------------------------
Glen Emelock
The CRO Group, Inc.
Melrose MA
United States
www.crogroup.com
------------------------------

Original Message:
Sent: 20-Jul-2017 15:01
From: LAURA HOSHUE
Subject: LED devices

Hi Colleagues,

I have a device that we are trying to launch in the US that has no currently marketed predicate.  FDA does not provide much guidance on LED devices, but I know that at a minimum, the device's intended use makes it a medical device and regulated.  It is to be inserted in the vagina and has LED as an energy source.

I want to know though whether the device, had it not been intended to treat certain conditions, and simply for cosmetic use, with the LED component, inserted in the vagina (not implanted), would still be considered a Class II device at a minimum? There are several LED devices to date that are used on the face for cosmetic use, that are not FDA cleared, unless treating acne etc. Does the anatomical site with the LED energy, pose a risk that makes the device automatically a regulated one? If we stay purely cosmetic, does the device itself automatically qualify as a regulated one because of its technological characteristics?

I know there's the De Novo and Pre sub process that we can explore, but this is for my own knowledge since FDA has no real guidance that I can find at least that states definitively that LED devices are regulated. 

Please advise.

Laura