Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!

Hello, the fees vary by consulting groups but in my experience would generally be around $25K to $40K depending on complexity of device and commensurate testing that needs to be submitted. There is also the FDA user fee which is $11594 for standard fee and $2899 for small business. There also significant costs with testing such as electrical safety, biocompatibility, shelf life, in vitro and in vivo performance testing depending on device type. Good luck with your project.

------------------------------
Ronald Warren RAC
San Diego CA
United States
------------------------------

Original Message:
Sent: 23-Apr-2020 12:35
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!

This message was posted by a user wishing to remain anonymous

Thanks for all the feedback. As others may be doing, we are looking at registering a surgical mask. This is outside of our traditional offerings and management needs clear information to make a sound decision. I would guess overall that this is around 200K, with testing included but wasn't sure how far off that is. Right now, we have a design and the ability to manufacture it but nothing else has been done. The facility is ISO 13485 certified but not currently a registered establishment.
Original Message:
Sent: 24-Apr-2020 03:39
From: Ronald Warren
Subject: 510(k) Cost Estimates including consultancy

Hello, the fees vary by consulting groups but in my experience would generally be around $25K to $40K depending on complexity of device and commensurate testing that needs to be submitted. There is also the FDA user fee which is $11594 for standard fee and $2899 for small business. There also significant costs with testing such as electrical safety, biocompatibility, shelf life, in vitro and in vivo performance testing depending on device type. Good luck with your project.

------------------------------
Ronald Warren RAC
San Diego CA
United States

Original Message:
Sent: 23-Apr-2020 12:35
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!

Original Message------

This message was posted by a user wishing to remain anonymous

Thanks for all the feedback. As others may be doing, we are looking at registering a surgical mask. This is outside of our traditional offerings and management needs clear information to make a sound decision. I would guess overall that this is around 200K, with testing included but wasn't sure how far off that is. Right now, we have a design and the ability to manufacture it but nothing else has been done. The facility is ISO 13485 certified but not currently a registered establishment.

I agree with Andrea - much of the information you need is captured in those guidance documents.  Read carefully, because under the right conditions with appropriate labeling, etc., a 510(k) prior to distribution of the product may not be necessary.

Good luck!

-Doug Ferguson

------------------------------
Douglas Ferguson
Founder and President
Metrowest Regulatory Associates, LLC
Sudbury MA
United States
------------------------------

Original Message:
Sent: 24-Apr-2020 19:15
From: Andrea Artman, MS, CQE, RAC
Subject: 510(k) Cost Estimates including consultancy

You should look into the guidance documents associated with the COVID response and 510(k)s. The most relevant for surgical masks are:

https://www.fda.gov/media/136449/download

https://www.fda.gov/media/136540/download

There is also a webinar that might interest you: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-enforcement-policy-personal-protective-equipment-ppe-during-covid-19-immediately-effect

Also note that some consultants, like us, are providing discounts for COVID specific work. 

I hope this is helpful! Thank you for your dedication to helping in the COVID response. 

Andrea Pilon Artman

President & Principal Consultant 

SpectRA Compliance, LLC 

D: 419-708-4172

Email: andrea.artman@spectracompliancellc.com

Original Message------

This message was posted by a user wishing to remain anonymous

Thanks for all the feedback. As others may be doing, we are looking at registering a surgical mask. This is outside of our traditional offerings and management needs clear information to make a sound decision. I would guess overall that this is around 200K, with testing included but wasn't sure how far off that is. Right now, we have a design and the ability to manufacture it but nothing else has been done. The facility is ISO 13485 certified but not currently a registered establishment.

Hi Anon,

Including the FDA fee, you are looking at $25-30,000. Add $5,000 if the device includes software. But of course it depends how much support you need for things like standards identification and compliance, test protocols, test reports, documentation formatting, etc.

Hope this helps. Get in touch if you would like to discuss further.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 23-Apr-2020 12:35
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!

Hello Anon,

I agree with the ranges from Ron and Roger.  Also agree that much depends on the type of device, how well understood it is, and whether or not the testing methods are also commonly used.  Happy to discuss directly if you wish to give you a better idea of what support your particular project would need.

------------------------------
Melissa Walker RAC
President & CTO
St Louis MO
United States
------------------------------

Original Message:
Sent: 23-Apr-2020 12:35
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!

Hello!  Congratulations on the prospect of filing a 510(k). I agree that it depends on the complexity of the 510(k), but these estimates are extremely conservative in my experience. From your initial message, it seems that you understand the testing and where you device stand in the scheme of your industry. Based on your question it also looks like you are looking less for regulatory strategy and more for expertise in 510(k) writing and communication with the FDA. 

That being said, I think the biggest difference you will see in pricing is the size or the consultancy you hire. Larger consultancies have more overhead that comes to you in cost where smaller independent consultants, with the same or even more experience, don't have the additional fiscal burden. 

I would urge you to find a consultant or consulting group that fits your specific needs and get quotes from a variety of consultancies.

Good Luck!

------------------------------
Andrea Pilon Artman, MS, CQE, RAC
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com
------------------------------

Original Message:
Sent: 24-Apr-2020 08:02
From: Melissa Walker
Subject: 510(k) Cost Estimates including consultancy

Hello Anon,

I agree with the ranges from Ron and Roger.  Also agree that much depends on the type of device, how well understood it is, and whether or not the testing methods are also commonly used.  Happy to discuss directly if you wish to give you a better idea of what support your particular project would need.

------------------------------
Melissa Walker RAC
President & CTO
St Louis MO
United States

Original Message:
Sent: 23-Apr-2020 12:35
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!

I am wondering whether the estimates provided are based on the assumption that the client already knows how to demonstrate that their device is substantial equivalent to a predicate, or whether it is assumed that the consultant will have to figure out what testing will be needed to demonstrate substantial equivalence, how the testing should be done (e.g. per guidances and/or standards), etc.  Is this what you mean by "steps to clear"?

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

Original Message:
Sent: 23-Apr-2020 12:35
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!

This message was posted by a user wishing to remain anonymous

Thanks, Julie. It is safe to assume that the consultant would need to determine what is needed to prove SE. This is an FXX mask and the company has not filed as the drug manufacturer of a med device in the past, just fulfilled obligations as a CMO (establishment registrations, QSR, FDA inspections).
Original Message:
Sent: 28-Apr-2020 17:15
From: Julie Omohundro
Subject: 510(k) Cost Estimates including consultancy

I am wondering is whether the estimates provided are based on the assumption that the client already knows how to demonstrate that their device is substantial equivalent to a predicate, or whether it is assumed that the consultant will have to figure out what testing will be needed to demonstrate substantial equivalence, how the testing should be done per guidances and/or standards), etc.  Is this what you mean by "steps to clear"?

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

Original Message:
Sent: 23-Apr-2020 12:35
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!

Original Message------

This message was posted by a user wishing to remain anonymous

Thanks, Julie. It is safe to assume that the consultant would need to determine what is needed to prove SE. This is an FXX mask and the company has not filed as the drug manufacturer of a med device in the past, just fulfilled obligations as a CMO (establishment registrations, QSR, FDA inspections).

HImm. I was taught a rather different wisdom about assuming, which is why I am asking instead of.

To my mind, this goes beyond assembling the dossier and assisting with "steps to clear."  I would interpret (for myself, but not assume that this is what the company is thinking), "steps to clear" from a regulatory consulting perspective as reviewing the submission against the RTA checklist, responding to deficiencies, etc. 

Determining what is needed to demonstrate SE is not always the role of an RA consultant.  Sometimes a company is capable of making that determination itself, collecting all the data needed to support it, and actually does need an RA consultant only to compile the dossier and assist with steps to clear.  Especially if they have only one RA person on staff, and that person is not sitting around with better nothing to do.

I would also be inclined to interpret "steps to clear" in the order you listed it, something that comes after a dossier has been compiled and therefore is available to be cleared.  Determining what is needed to demonstrate SE is something that has to happen well before compilation, or there is nothing to compile.

I asked the question because I was interested in whether those who offered estimates had made an assumption one way or another, or perhaps if the wide range of some estimates was wide because they allowed for all possible interpretations.

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

Original Message:
Sent: 28-Apr-2020 17:23
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

Thanks, Julie. It is safe to assume that the consultant would need to determine what is needed to prove SE. This is an FXX mask and the company has not filed as the drug manufacturer of a med device in the past, just fulfilled obligations as a CMO (establishment registrations, QSR, FDA inspections).
Original Message:
Sent: 28-Apr-2020 17:15
From: Julie Omohundro
Subject: 510(k) Cost Estimates including consultancy

I am wondering is whether the estimates provided are based on the assumption that the client already knows how to demonstrate that their device is substantial equivalent to a predicate, or whether it is assumed that the consultant will have to figure out what testing will be needed to demonstrate substantial equivalence, how the testing should be done per guidances and/or standards), etc.  Is this what you mean by "steps to clear"?

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

Original Message:
Sent: 23-Apr-2020 12:35
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!

And thinking further...

If it is a CMO that is planning to do a true "me too," (because it has found a product it thinks it can provide at lower cost, not by cutting out the middleman (itself), but by becoming its own client, so there is no middleman), then that is a relatively...dare I say the word...straightforward process.  The technical complexity and intended use of the device will affect RA costs, because these will determine how much content needs to be assembled.

On the other hand, if it is a CMO that has decided to get innovative...I personally would not even hazard a guess on the cost. It's like trying to turn a pumpkin into a carriage, only no magic.

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

Original Message:
Sent: 29-Apr-2020 11:27
From: Julie Omohundro
Subject: 510(k) Cost Estimates including consultancy

HImm. I was taught a rather different wisdom about assuming, which is why I am asking instead of.

To my mind, this goes beyond assembling the dossier and assisting with "steps to clear."  I would interpret (for myself, but not assume that this is what the company is thinking), "steps to clear" from a regulatory consulting perspective as reviewing the submission against the RTA checklist, responding to deficiencies, etc.

Determining what is needed to demonstrate SE is not always the role of an RA consultant.  Sometimes a company is capable of making that determination itself, collecting all the data needed to support it, and actually does need an RA consultant only to compile the dossier and assist with steps to clear.  Especially if they have only one RA person on staff, and that person is not sitting around with better nothing to do.

I would also be inclined to interpret "steps to clear" in the order you listed it, something that comes after a dossier has been compiled and therefore is available to be cleared.  Determining what is needed to demonstrate SE is something that has to happen well before compilation, or there is nothing to compile.

I asked the question because I was interested in whether those who offered estimates had made an assumption one way or another, or perhaps if the wide range of some estimates was wide because they allowed for all possible interpretations.

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

Original Message:
Sent: 28-Apr-2020 17:23
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

Thanks, Julie. It is safe to assume that the consultant would need to determine what is needed to prove SE. This is an FXX mask and the company has not filed as the drug manufacturer of a med device in the past, just fulfilled obligations as a CMO (establishment registrations, QSR, FDA inspections).
Original Message:
Sent: 28-Apr-2020 17:15
From: Julie Omohundro
Subject: 510(k) Cost Estimates including consultancy

I am wondering is whether the estimates provided are based on the assumption that the client already knows how to demonstrate that their device is substantial equivalent to a predicate, or whether it is assumed that the consultant will have to figure out what testing will be needed to demonstrate substantial equivalence, how the testing should be done per guidances and/or standards), etc.  Is this what you mean by "steps to clear"?

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

Original Message:
Sent: 23-Apr-2020 12:35
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!

If the company is planning to jump aboard the COVID-19 bandwagon, I think it might be a rather late to this party.  My recommendation (since you didn't ask) would be that the company take a hard look at both supply and demand before investing in this effort. 

On the one hand, there are a whole lot of companies (claiming that they are) already cranking out FXX masks as fast as they can.  On the flip side, curves are flattening all over, states and countries are starting to re-open.  First the UK needed a whole bunch of ventilators, and a matter of weeks later, not so many after all. 

While some players are hoping for a surge or a second wave to keep demand alive, even if there is one, if the companies claiming to be cranking out large volumes of masks at lightspeed are actually doing so, they probably got it covered.  Otherwise we might see the price of PPE tank seriously in another 6 months or so, do to supply dwarfing demand.

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

Original Message:
Sent: 28-Apr-2020 17:23
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

Thanks, Julie. It is safe to assume that the consultant would need to determine what is needed to prove SE. This is an FXX mask and the company has not filed as the drug manufacturer of a med device in the past, just fulfilled obligations as a CMO (establishment registrations, QSR, FDA inspections).
Original Message:
Sent: 28-Apr-2020 17:15
From: Julie Omohundro
Subject: 510(k) Cost Estimates including consultancy

I am wondering is whether the estimates provided are based on the assumption that the client already knows how to demonstrate that their device is substantial equivalent to a predicate, or whether it is assumed that the consultant will have to figure out what testing will be needed to demonstrate substantial equivalence, how the testing should be done per guidances and/or standards), etc.  Is this what you mean by "steps to clear"?

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

Original Message:
Sent: 23-Apr-2020 12:35
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!

Just to wrap this up, I think consultants should be able to give you a fairly tight range in a cost estimate based on the knowledge that it is an FXX mask and that the company has no prior experience on the development side.  Even tighter if you can confirm whether it is a true "me too" or an "innovative" product.  Regardless, the estimate is only as good as the scope of work that the consultant is basing their estimate on, so you will want to be clear on that.

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

Original Message:
Sent: 28-Apr-2020 17:23
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

Thanks, Julie. It is safe to assume that the consultant would need to determine what is needed to prove SE. This is an FXX mask and the company has not filed as the drug manufacturer of a med device in the past, just fulfilled obligations as a CMO (establishment registrations, QSR, FDA inspections).
Original Message:
Sent: 28-Apr-2020 17:15
From: Julie Omohundro
Subject: 510(k) Cost Estimates including consultancy

I am wondering is whether the estimates provided are based on the assumption that the client already knows how to demonstrate that their device is substantial equivalent to a predicate, or whether it is assumed that the consultant will have to figure out what testing will be needed to demonstrate substantial equivalence, how the testing should be done per guidances and/or standards), etc.  Is this what you mean by "steps to clear"?

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

Original Message:
Sent: 23-Apr-2020 12:35
From: Anonymous Member
Subject: 510(k) Cost Estimates including consultancy

This message was posted by a user wishing to remain anonymous

I would like to get a feel for the costs associated with filing a 510(k). Let's assume that this company has experience contact manufacturing simple Class II med devices as a CMO and is looking to file its own 510(k) for a different Class II (non-exempt) device. As with similar companies to mine, I am the sole regulatory member on staff and we would need to hire consultants to assemble the dossier and assist with steps to clear. The manufacturing facility is largely capable of meeting all QSR requirements today.
Thanks in advance!