Regulatory Open Forum

​In order to determine the classification of a device, I've always started with a search for a predicate.  If I can find one, then the device has the same classification as the predicate.  If I can't, it's a novel device, and must be the subject of a De novo or a PMA.

Recently I've learned that some people take a different approach, which seems consistent with FDA's guidance here:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm

FDA's guidance doesn't make any sense to me, because it seems to be based on the assumption that you already know what your device is, and rather than actually "determining" its classification, you just need to find your device in the database, where its classification has already been determined.  

The only time this approach seems really appropriate to me is in the case of a manufacturer that is going to make exactly the same device made by other manufacturers. Otherwise, any differences between the device and other devices in the same product code would raise the question of substantial equivalence.  Apparently there are those who are of the opinion that, if the chosen product code indicates that the device is 510(k) exempt, it isn't necessary to consider whether the device is substantially equivalent to any of the other devices with the same product code. 

This seems wrong to me, but I've worked mostly with novel devices, and with some devices that require a 510(k).  I'm hoping some of the folks here whose experience is broader than mine might be able to clarify this for me.







------------------------------
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
------------------------------

Julie,
I typically search the regulations and subsequent product codes based on my understanding of the device. If there is an existing regulation and/or product code that seems to cover my device, then I look under the registrations and listings to see other products in that product code. If the devices are similar enough in technology and intended use, then I use that classification which could lead to 510(k) exempt. Other times this method provides a good list of potential predicates. I hope that helps.

Mike

------------------------------
Michael Nilo
Network Regulatory Partners
Portland OR
United States
------------------------------

Original Message:
Sent: 20-Dec-2017 22:58
From: Julie Omohundro
Subject: Classification via Product Code vs Predicate

​In order to determine the classification of a device, I've always started with a search for a predicate.  If I can find one, then the device has the same classification as the predicate.  If I can't, it's a novel device, and must be the subject of a De novo or a PMA.

Recently I've learned that some people take a different approach, which seems consistent with FDA's guidance here:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm

FDA's guidance doesn't make any sense to me, because it seems to be based on the assumption that you already know what your device is, and rather than actually "determining" its classification, you just need to find your device in the database, where its classification has already been determined.

The only time this approach seems really appropriate to me is in the case of a manufacturer that is going to make exactly the same device made by other manufacturers. Otherwise, any differences between the device and other devices in the same product code would raise the question of substantial equivalence.  Apparently there are those who are of the opinion that, if the chosen product code indicates that the device is 510(k) exempt, it isn't necessary to consider whether the device is substantially equivalent to any of the other devices with the same product code.

This seems wrong to me, but I've worked mostly with novel devices, and with some devices that require a 510(k).  I'm hoping some of the folks here whose experience is broader than mine might be able to clarify this for me.







------------------------------
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
------------------------------

​Michael, I appreciate you sharing your thoughts on this.  As I said, I think that, properly applied, the two approaches end up at the same place.  When you say, " If the devices are similar enough in technology and intended use...,"  is this not saying "If the device is substantially equivalent to other products in that product code..."?

------------------------------
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-Dec-2017 13:22
From: Michael Nilo
Subject: Classification via Product Code vs Predicate

Julie,
I typically search the regulations and subsequent product codes based on my understanding of the device. If there is an existing regulation and/or product code that seems to cover my device, then I look under the registrations and listings to see other products in that product code. If the devices are similar enough in technology and intended use, then I use that classification which could lead to 510(k) exempt. Other times this method provides a good list of potential predicates. I hope that helps.

Mike

------------------------------
Michael Nilo
Network Regulatory Partners
Portland OR
United States

Original Message:
Sent: 20-Dec-2017 22:58
From: Julie Omohundro
Subject: Classification via Product Code vs Predicate

​In order to determine the classification of a device, I've always started with a search for a predicate.  If I can find one, then the device has the same classification as the predicate.  If I can't, it's a novel device, and must be the subject of a De novo or a PMA.

Recently I've learned that some people take a different approach, which seems consistent with FDA's guidance here:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm

FDA's guidance doesn't make any sense to me, because it seems to be based on the assumption that you already know what your device is, and rather than actually "determining" its classification, you just need to find your device in the database, where its classification has already been determined.

The only time this approach seems really appropriate to me is in the case of a manufacturer that is going to make exactly the same device made by other manufacturers. Otherwise, any differences between the device and other devices in the same product code would raise the question of substantial equivalence.  Apparently there are those who are of the opinion that, if the chosen product code indicates that the device is 510(k) exempt, it isn't necessary to consider whether the device is substantially equivalent to any of the other devices with the same product code.

This seems wrong to me, but I've worked mostly with novel devices, and with some devices that require a 510(k).  I'm hoping some of the folks here whose experience is broader than mine might be able to clarify this for me.







------------------------------
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
------------------------------

This message was posted by a user wishing to remain anonymous

​

Mike, please could you clarify…

Starting from the Regulation and/or Product Code, it could be difficult if not impossible to find equivalent devices (i.e. devices with the same intended use and using similar technology) listed under the Registrations & Listings database, if the device is 510(k) exempt.

FDA requires firms to list the Proprietary Names but in absence of the 510(k) Summary or Statement the names as shown may or may not provide adequate detail to allow any meaningful device comparison, even by searching the manufacturer's website for the possible intended use and technology.

Take the example of 'Components, Wheelchair' under Regulation 890.3920, with Product Code KNN, which are Class 1 devices 510(k) exempt. A search of the Registrations & Listings database for 'KNN' in the Product Code field yields numerous entries, but most entries simply show under Proprietary Name either the company's name or cite "various" or "multiple" or some terminology that would not allow one to identify the particular device.  FDA also allows device manufacturers (i.e. Owner Operator / Registered Establishment) the option to list their device as confidential commercial information, meaning the Proprietary Name is not available for viewing by the public.

Manufacturers of devices that could possibly be 510(k) exempt require other means of confirming that the appropriate Regulation and Product Code has been correctly applied, without having to labor through a Q-sub or a de-novo.

It would be interesting to learn from the experiences of this learned forum.

Happy holidays!

Original Message:
Sent: 21-Dec-2017 13:22
From: Michael Nilo
Subject: Classification via Product Code vs Predicate

Julie,
I typically search the regulations and subsequent product codes based on my understanding of the device. If there is an existing regulation and/or product code that seems to cover my device, then I look under the registrations and listings to see other products in that product code. If the devices are similar enough in technology and intended use, then I use that classification which could lead to 510(k) exempt. Other times this method provides a good list of potential predicates. I hope that helps.

Mike

------------------------------
Michael Nilo
Network Regulatory Partners
Portland OR
United States

Original Message:
Sent: 20-Dec-2017 22:58
From: Julie Omohundro
Subject: Classification via Product Code vs Predicate

​In order to determine the classification of a device, I've always started with a search for a predicate.  If I can find one, then the device has the same classification as the predicate.  If I can't, it's a novel device, and must be the subject of a De novo or a PMA.

Recently I've learned that some people take a different approach, which seems consistent with FDA's guidance here:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm

FDA's guidance doesn't make any sense to me, because it seems to be based on the assumption that you already know what your device is, and rather than actually "determining" its classification, you just need to find your device in the database, where its classification has already been determined.

The only time this approach seems really appropriate to me is in the case of a manufacturer that is going to make exactly the same device made by other manufacturers. Otherwise, any differences between the device and other devices in the same product code would raise the question of substantial equivalence.  Apparently there are those who are of the opinion that, if the chosen product code indicates that the device is 510(k) exempt, it isn't necessary to consider whether the device is substantially equivalent to any of the other devices with the same product code.

This seems wrong to me, but I've worked mostly with novel devices, and with some devices that require a 510(k).  I'm hoping some of the folks here whose experience is broader than mine might be able to clarify this for me.







------------------------------
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
------------------------------