Regulatory Open Forum

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses. 

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.  

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Hi William,

Elastic Bandages are Class 1, which means the two devices (880.5075 Elastic bandages) you are kitting, were are legally marketed exempt from GMPs and premarket notification.  Your "Wound Dressing Kit" is afforded Enforcement discretion from premarket notification per the Convenience Kit Guidance. 

Two points.  First, if you create a ANY kit of devices for which you are not the manufacturer, you would be required to submit your own 510(k).  However in the Convenience Kit Guidance, FDA has decided to use their "Enforcement Discretion" and does not require a submission.

Second, the classification you reference ("Wound Dressing Kit") covers kits that can contain more then just class 1 devices. 

So, if you are the manufacturer of both devices, the packaging of two of your class 1 device is still class 1.  However, if you are NOT the manufacturer of the devices, your kit is exempt from premarket notification.

This may sound confusing, but I hope it helps clarify your situation.



------------------------------
Lee Leichter RAC
President
Fort Myers FL
United States
------------------------------

Original Message:
Sent: 25-Jun-2021 16:48
From: William Coulston
Subject: Device Convenience Kit - submit or not submit?

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses.

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Hi Lee, 

I am currently working on something similar to this... what is your advice when it comes to the UDI codes for the kit William inquired on?

------------------------------
Sari Luciano
Oakland CA
United States
------------------------------

Original Message:
Sent: 26-Jun-2021 07:37
From: Lee Leichter
Subject: Device Convenience Kit - submit or not submit?

Hi William,

Elastic Bandages are Class 1, which means the two devices (880.5075 Elastic bandages) you are kitting, were are legally marketed exempt from GMPs and premarket notification.  Your "Wound Dressing Kit" is afforded Enforcement discretion from premarket notification per the Convenience Kit Guidance.

Two points.  First, if you create a ANY kit of devices for which you are not the manufacturer, you would be required to submit your own 510(k).  However in the Convenience Kit Guidance, FDA has decided to use their "Enforcement Discretion" and does not require a submission.

Second, the classification you reference ("Wound Dressing Kit") covers kits that can contain more then just class 1 devices.

So, if you are the manufacturer of both devices, the packaging of two of your class 1 device is still class 1.  However, if you are NOT the manufacturer of the devices, your kit is exempt from premarket notification.

This may sound confusing, but I hope it helps clarify your situation.



------------------------------
Lee Leichter RAC
President
Fort Myers FL
United States

Original Message:
Sent: 25-Jun-2021 16:48
From: William Coulston
Subject: Device Convenience Kit - submit or not submit?

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses.

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Original Message:
Sent: 6/26/2021 4:27:00 PM
From: Sari Luciano
Subject: RE: Device Convenience Kit - submit or not submit?

Hi Lee, 

I am currently working on something similar to this... what is your advice when it comes to the UDI codes for the kit William inquired on?

------------------------------
Sari Luciano
Oakland CA
United States
------------------------------

Original Message:
Sent: 26-Jun-2021 07:37
From: Lee Leichter
Subject: Device Convenience Kit - submit or not submit?

Hi William,

Elastic Bandages are Class 1, which means the two devices (880.5075 Elastic bandages) you are kitting, were are legally marketed exempt from GMPs and premarket notification.  Your "Wound Dressing Kit" is afforded Enforcement discretion from premarket notification per the Convenience Kit Guidance.

Two points.  First, if you create a ANY kit of devices for which you are not the manufacturer, you would be required to submit your own 510(k).  However in the Convenience Kit Guidance, FDA has decided to use their "Enforcement Discretion" and does not require a submission.

Second, the classification you reference ("Wound Dressing Kit") covers kits that can contain more then just class 1 devices.

So, if you are the manufacturer of both devices, the packaging of two of your class 1 device is still class 1.  However, if you are NOT the manufacturer of the devices, your kit is exempt from premarket notification.

This may sound confusing, but I hope it helps clarify your situation.



------------------------------
Lee Leichter RAC
President
Fort Myers FL
United States

Original Message:
Sent: 25-Jun-2021 16:48
From: William Coulston
Subject: Device Convenience Kit - submit or not submit?

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses.

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Hi William

A reminder that exemptions come with the ubiquitous limitation.   If you promote claims outside the description of the description in the formal classification, then you can put the exemption at risk, even if it is a wound dressing.  E.g., claims that "using the wound dressing " heals faster and reduces pain and reinfection, etc....  "

This is true of any device classification the wording on exemptions limitations apply.  And you also need to be extra careful around pain claims, even simple ones.  That enters the drug world, drawing CDER ire. 

Good luck.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 26-Jun-2021 07:37
From: Lee Leichter
Subject: Device Convenience Kit - submit or not submit?

Hi William,

Elastic Bandages are Class 1, which means the two devices (880.5075 Elastic bandages) you are kitting, were are legally marketed exempt from GMPs and premarket notification.  Your "Wound Dressing Kit" is afforded Enforcement discretion from premarket notification per the Convenience Kit Guidance.

Two points.  First, if you create a ANY kit of devices for which you are not the manufacturer, you would be required to submit your own 510(k).  However in the Convenience Kit Guidance, FDA has decided to use their "Enforcement Discretion" and does not require a submission.

Second, the classification you reference ("Wound Dressing Kit") covers kits that can contain more then just class 1 devices.

So, if you are the manufacturer of both devices, the packaging of two of your class 1 device is still class 1.  However, if you are NOT the manufacturer of the devices, your kit is exempt from premarket notification.

This may sound confusing, but I hope it helps clarify your situation.



------------------------------
Lee Leichter RAC
President
Fort Myers FL
United States

Original Message:
Sent: 25-Jun-2021 16:48
From: William Coulston
Subject: Device Convenience Kit - submit or not submit?

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses.

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Ginger,

Can you give me some specific examples of components that may go in a wound dressing kit?  For example, could I put a bottle of antimicrobial solution with a tube of antimicrobial gel and call it wound dressing kit?

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Original Message:
Sent: 27-Jun-2021 07:52
From: Ginger Cantor
Subject: Device Convenience Kit - submit or not submit?

Hi William

A reminder that exemptions come with the ubiquitous limitation.   If you promote claims outside the description of the description in the formal classification, then you can put the exemption at risk, even if it is a wound dressing.  E.g., claims that "using the wound dressing " heals faster and reduces pain and reinfection, etc....  "

This is true of any device classification the wording on exemptions limitations apply.  And you also need to be extra careful around pain claims, even simple ones.  That enters the drug world, drawing CDER ire.

Good luck.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 26-Jun-2021 07:37
From: Lee Leichter
Subject: Device Convenience Kit - submit or not submit?

Hi William,

Elastic Bandages are Class 1, which means the two devices (880.5075 Elastic bandages) you are kitting, were are legally marketed exempt from GMPs and premarket notification.  Your "Wound Dressing Kit" is afforded Enforcement discretion from premarket notification per the Convenience Kit Guidance.

Two points.  First, if you create a ANY kit of devices for which you are not the manufacturer, you would be required to submit your own 510(k).  However in the Convenience Kit Guidance, FDA has decided to use their "Enforcement Discretion" and does not require a submission.

Second, the classification you reference ("Wound Dressing Kit") covers kits that can contain more then just class 1 devices.

So, if you are the manufacturer of both devices, the packaging of two of your class 1 device is still class 1.  However, if you are NOT the manufacturer of the devices, your kit is exempt from premarket notification.

This may sound confusing, but I hope it helps clarify your situation.



------------------------------
Lee Leichter RAC
President
Fort Myers FL
United States

Original Message:
Sent: 25-Jun-2021 16:48
From: William Coulston
Subject: Device Convenience Kit - submit or not submit?

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses.

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Original Message:
Sent: 6/28/2021 1:54:00 PM
From: William Coulston
Subject: RE: Device Convenience Kit - submit or not submit?

Ginger,

Can you give me some specific examples of components that may go in a wound dressing kit?  For example, could I put a bottle of antimicrobial solution with a tube of antimicrobial gel and call it wound dressing kit?

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Original Message:
Sent: 27-Jun-2021 07:52
From: Ginger Cantor
Subject: Device Convenience Kit - submit or not submit?

Hi William

A reminder that exemptions come with the ubiquitous limitation.   If you promote claims outside the description of the description in the formal classification, then you can put the exemption at risk, even if it is a wound dressing.  E.g., claims that "using the wound dressing " heals faster and reduces pain and reinfection, etc....  "

This is true of any device classification the wording on exemptions limitations apply.  And you also need to be extra careful around pain claims, even simple ones.  That enters the drug world, drawing CDER ire.

Good luck.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 26-Jun-2021 07:37
From: Lee Leichter
Subject: Device Convenience Kit - submit or not submit?

Hi William,

Elastic Bandages are Class 1, which means the two devices (880.5075 Elastic bandages) you are kitting, were are legally marketed exempt from GMPs and premarket notification.  Your "Wound Dressing Kit" is afforded Enforcement discretion from premarket notification per the Convenience Kit Guidance.

Two points.  First, if you create a ANY kit of devices for which you are not the manufacturer, you would be required to submit your own 510(k).  However in the Convenience Kit Guidance, FDA has decided to use their "Enforcement Discretion" and does not require a submission.

Second, the classification you reference ("Wound Dressing Kit") covers kits that can contain more then just class 1 devices.

So, if you are the manufacturer of both devices, the packaging of two of your class 1 device is still class 1.  However, if you are NOT the manufacturer of the devices, your kit is exempt from premarket notification.

This may sound confusing, but I hope it helps clarify your situation.



------------------------------
Lee Leichter RAC
President
Fort Myers FL
United States

Original Message:
Sent: 25-Jun-2021 16:48
From: William Coulston
Subject: Device Convenience Kit - submit or not submit?

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses.

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Original Message:
Sent: 6/25/2021 4:48:00 PM
From: William Coulston
Subject: Device Convenience Kit - submit or not submit?

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses. 

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.  

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

This message was posted by a user wishing to remain anonymous

John,

I haven't dealt with kits either.  It seems like this kit must contain a bandage in addition to other "wound dressings", e.g. hydrogels, powders, etc., that may be included in the kit, based on the regulation number.   Is this correct?  What are some examples of components of wound dressing kits?
Original Message:
Sent: 26-Jun-2021 17:46
From: John Beasley
Subject: Device Convenience Kit - submit or not submit?

Hello Mr. Coulston,

Your convenience kit, MCY procode, is not exempt from 510(k).  However, FDA uses Enforcement Discretion and unless specifically asked, a 510(k) submission is not required to market, given that all criteria in the guidance are met.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview

257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message:
Sent: 6/25/2021 4:48:00 PM
From: William Coulston
Subject: Device Convenience Kit - submit or not submit?

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses.

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Related to this question, what are the requirements for applying design controls for FDA Class 2 convenience kits? I am particularly interested in whether/how design controls apply to a firm that packages, labels, distributes convenience kits incorporating legally marketed FDA Class 1 and Class 2 devices that are not modified in any way.
Original Message:
Sent: 25-Jun-2021 16:48
From: William Coulston
Subject: Device Convenience Kit - submit or not submit?

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses.

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Anonymous,

A kit assembler is a manufacturer per 807.20(a).  Design controls apply as the general controls required by the QSR and other regulations.  

Respectfully,

will

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Original Message:
Sent: 27-Jun-2021 15:10
From: Anonymous Member
Subject: Device Convenience Kit - submit or not submit?

This message was posted by a user wishing to remain anonymous

Related to this question, what are the requirements for applying design controls for FDA Class 2 convenience kits? I am particularly interested in whether/how design controls apply to a firm that packages, labels, distributes convenience kits incorporating legally marketed FDA Class 1 and Class 2 devices that are not modified in any way.
Original Message:
Sent: 25-Jun-2021 16:48
From: William Coulston
Subject: Device Convenience Kit - submit or not submit?

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses.

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Original Message:
Sent: 6/28/2021 10:40:00 AM
From: William Coulston
Subject: RE: Device Convenience Kit - submit or not submit?

Anonymous,

A kit assembler is a manufacturer per 807.20(a).  Design controls apply as the general controls required by the QSR and other regulations.  

Respectfully,

will

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Original Message:
Sent: 27-Jun-2021 15:10
From: Anonymous Member
Subject: Device Convenience Kit - submit or not submit?

This message was posted by a user wishing to remain anonymous

Related to this question, what are the requirements for applying design controls for FDA Class 2 convenience kits? I am particularly interested in whether/how design controls apply to a firm that packages, labels, distributes convenience kits incorporating legally marketed FDA Class 1 and Class 2 devices that are not modified in any way.
Original Message:
Sent: 25-Jun-2021 16:48
From: William Coulston
Subject: Device Convenience Kit - submit or not submit?

Hello All,

I hope you are well and getting back to some normalcy.  I have a convenience kit comprised of two cleared wound dressing devices which are unclassified.  They will each maintain their separate, cleared label and package insert, i.e. no combining into one amalgamated label.  Other than putting them in a box together there will be no other changes to the devices.  They will be used according to their cleared intended and indicated uses.

They fall within the MCY procode (880.5057).  This is were I'm a little confused as the procode is Class II but the regulation is Class I.  So is my convenience kit 510(K) exempt?  My analysis based on the FDA guidance says there are not different risks or significantly changed existing risks, document.

Can you clear up my confusion?  Any guidance is appreciated as I haven't dealt with kits.

------------------------------
William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------