Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Recently I have been doing research on 510k exemptions and how they work.

My understanding is that as long as a new product complies with the Regulation Number and follows 21 CFR 890.9 it can be registered and marketed without 510k clearance in the US.

My question arises after seeing a 510k clearance for a product after the exemption had occurred. The product must have needed clearance due to not conforming with all criteria of the 21 CFR 890.9 document.

I read through a blog post found at 510(k) Exemption - What's Actually Exempt Part II that has a quote from the FDA saying "When a company submits a 510(k) for a device under a 510(k) exempt regulation, it is because the device exceeded the limitations of exemption for that regulation.  If the device is then found substantially equivalent, the technology and/or indications newly cleared within that 510(k) would then expand the limitations of exemption within that regulation". 

My question is with the phrasing of "expanding the limitations" quote. Does a post-exemption 510k clearance expand the indications for use/Fundamental Scientific Technology for all products that come after? Am I understanding that correctly?

-Thanks!

Basically you would start with the Product Code for the product you are looking at that gives an indication for the Class of device and whether a 510(k) is required or not.  The FDA has done a great job with the database Product Classification with the information there about each device types.  Probably outside of this discussion, but there are devices unclassified, De Novo, and whether a device is a medical device or not.  Now there are a small number of devices that are Class I requiring a 510(k) and a few that are Class II that are 510(k) Exempt.  You are correct in understanding that a 510(k) Exempt device that needs a 510(k) is because it has exceeded the limitations under section 8xx.9.  This basically means that if the device has indications, features, or functionality that do not fall under the regulation number or product code then it "exceeds" the regulation.  As a quick example, if there is a device indicated for 'x' that is 510(k) Exempt, but then a change is made to add indication 'y' (claim) and feature 'z' that exceeds the regulation, then a new 510(k) would be needed.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 01-Nov-2018 12:58
From: Anonymous Member
Subject: 510k Exemptions

This message was posted by a user wishing to remain anonymous

Recently I have been doing research on 510k exemptions and how they work.

My understanding is that as long as a new product complies with the Regulation Number and follows 21 CFR 890.9 it can be registered and marketed without 510k clearance in the US.

My question arises after seeing a 510k clearance for a product after the exemption had occurred. The product must have needed clearance due to not conforming with all criteria of the 21 CFR 890.9 document.

I read through a blog post found at 510(k) Exemption - What's Actually Exempt Part II that has a quote from the FDA saying "When a company submits a 510(k) for a device under a 510(k) exempt regulation, it is because the device exceeded the limitations of exemption for that regulation.  If the device is then found substantially equivalent, the technology and/or indications newly cleared within that 510(k) would then expand the limitations of exemption within that regulation".

My question is with the phrasing of "expanding the limitations" quote. Does a post-exemption 510k clearance expand the indications for use/Fundamental Scientific Technology for all products that come after? Am I understanding that correctly?

-Thanks!

This message was posted by a user wishing to remain anonymous

Thanks Richard. Good Info.

To tack on a question on to your example. If the device indicated for 'x' and indication 'y' and feature 'z' gets 510(k) clearance for the new indications and features, are all new devices under that same Product Code 510(k) exempt with indications 'x' and 'y' and feature 'z'?
Original Message:
Sent: 02-Nov-2018 10:38
From: Richard Vincins
Subject: 510k Exemptions

Basically you would start with the Product Code for the product you are looking at that gives an indication for the Class of device and whether a 510(k) is required or not.  The FDA has done a great job with the database Product Classification with the information there about each device types.  Probably outside of this discussion, but there are devices unclassified, De Novo, and whether a device is a medical device or not.  Now there are a small number of devices that are Class I requiring a 510(k) and a few that are Class II that are 510(k) Exempt.  You are correct in understanding that a 510(k) Exempt device that needs a 510(k) is because it has exceeded the limitations under section 8xx.9.  This basically means that if the device has indications, features, or functionality that do not fall under the regulation number or product code then it "exceeds" the regulation.  As a quick example, if there is a device indicated for 'x' that is 510(k) Exempt, but then a change is made to add indication 'y' (claim) and feature 'z' that exceeds the regulation, then a new 510(k) would be needed.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 01-Nov-2018 12:58
From: Anonymous Member
Subject: 510k Exemptions

This message was posted by a user wishing to remain anonymous

Recently I have been doing research on 510k exemptions and how they work.

My understanding is that as long as a new product complies with the Regulation Number and follows 21 CFR 890.9 it can be registered and marketed without 510k clearance in the US.

My question arises after seeing a 510k clearance for a product after the exemption had occurred. The product must have needed clearance due to not conforming with all criteria of the 21 CFR 890.9 document.

I read through a blog post found at 510(k) Exemption - What's Actually Exempt Part II that has a quote from the FDA saying "When a company submits a 510(k) for a device under a 510(k) exempt regulation, it is because the device exceeded the limitations of exemption for that regulation.  If the device is then found substantially equivalent, the technology and/or indications newly cleared within that 510(k) would then expand the limitations of exemption within that regulation".

My question is with the phrasing of "expanding the limitations" quote. Does a post-exemption 510k clearance expand the indications for use/Fundamental Scientific Technology for all products that come after? Am I understanding that correctly?

-Thanks!

Nope, it would just mean that the devices now that are cleared under the 510(k) number 'Kxxxx' for the x, y, z indications could now be used as a predicate device for subsequent devices including competitive products.  The original Product Code would still remain; if you look around some there are 510(k) Exempt product codes with dozens of 510(k)s cleared following your add-on question.  Sometimes if FDA sees there are specific type of devices they may create a new Product Code.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 02-Nov-2018 11:17
From: Anonymous Member
Subject: 510k Exemptions

This message was posted by a user wishing to remain anonymous

Thanks Richard. Good Info.

To tack on a question on to your example. If the device indicated for 'x' and indication 'y' and feature 'z' gets 510(k) clearance for the new indications and features, are all new devices under that same Product Code 510(k) exempt with indications 'x' and 'y' and feature 'z'?
Original Message:
Sent: 02-Nov-2018 10:38
From: Richard Vincins
Subject: 510k Exemptions

Basically you would start with the Product Code for the product you are looking at that gives an indication for the Class of device and whether a 510(k) is required or not.  The FDA has done a great job with the database Product Classification with the information there about each device types.  Probably outside of this discussion, but there are devices unclassified, De Novo, and whether a device is a medical device or not.  Now there are a small number of devices that are Class I requiring a 510(k) and a few that are Class II that are 510(k) Exempt.  You are correct in understanding that a 510(k) Exempt device that needs a 510(k) is because it has exceeded the limitations under section 8xx.9.  This basically means that if the device has indications, features, or functionality that do not fall under the regulation number or product code then it "exceeds" the regulation.  As a quick example, if there is a device indicated for 'x' that is 510(k) Exempt, but then a change is made to add indication 'y' (claim) and feature 'z' that exceeds the regulation, then a new 510(k) would be needed.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 01-Nov-2018 12:58
From: Anonymous Member
Subject: 510k Exemptions

This message was posted by a user wishing to remain anonymous

Recently I have been doing research on 510k exemptions and how they work.

My understanding is that as long as a new product complies with the Regulation Number and follows 21 CFR 890.9 it can be registered and marketed without 510k clearance in the US.

My question arises after seeing a 510k clearance for a product after the exemption had occurred. The product must have needed clearance due to not conforming with all criteria of the 21 CFR 890.9 document.

I read through a blog post found at 510(k) Exemption - What's Actually Exempt Part II that has a quote from the FDA saying "When a company submits a 510(k) for a device under a 510(k) exempt regulation, it is because the device exceeded the limitations of exemption for that regulation.  If the device is then found substantially equivalent, the technology and/or indications newly cleared within that 510(k) would then expand the limitations of exemption within that regulation".

My question is with the phrasing of "expanding the limitations" quote. Does a post-exemption 510k clearance expand the indications for use/Fundamental Scientific Technology for all products that come after? Am I understanding that correctly?

-Thanks!