Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi 

I am writing up a regulatory plan for 510K exempt immunoassays with a new detection technology for launch of these assays in US, Canada, Brazil & Mexico.

The assays were previously cleared by FDA.

I have a few questions related to this:

1. What path to undertake for approval  or registration from FDA   (510 K exempt or new 510 K submission) 
2. Procedure to register the assays on the FDA website
3. Would FDA like to see all the performance data in comparison to predicate 
4.  Time lines for registration
5. which link should I use for registration of the new assays.

I shall very much appreciate your help.

Thankyou!

Hello Anon,

With limited information, not knowing the type of IA the answers to provide are not going to be so clear.  Plus your information is a bit confusing because you state writing a regulatory plan for a 510(k) Exempt device, but your first question is asking about a pathway for 510(k) Exempt of 510(k) submission.

1. The answer to this question really depends on the IA, the Product Code, and the Registration number.  If indeed the product is 510(k) Exempt, then you only need to register the product through the Medical Device Listing.  However, as you say a new 510(k) submission, so this would ask the question if you are changing the indication for use or something else that would no longer make it exempt.
2. Registration of a product is done through the Medical Device Listing page through a FURLS account: https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list.
3. Answer to this question depends on the IA, whether a 510(k) is required, and what type of performance testing is currently existing.  There are many factors going into whether comparative performance testing is required, but some assays indeed have comparison testing done as part of the analytical testing and performance testing.
4. Registration - medical device listing only takes a little time as this is done through the FURLS database.
5. See above.

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

Original Message:
Sent: 12-Jun-2020 10:27
From: Anonymous Member
Subject: 510K exempt assays

This message was posted by a user wishing to remain anonymous

Hi

I am writing up a regulatory plan for 510K exempt immunoassays with a new detection technology for launch of these assays in US, Canada, Brazil & Mexico.

The assays were previously cleared by FDA.

I have a few questions related to this:

1. What path to undertake for approval  or registration from FDA   (510 K exempt or new 510 K submission)
2. Procedure to register the assays on the FDA website
3. Would FDA like to see all the performance data in comparison to predicate
4.  Time lines for registration
5. which link should I use for registration of the new assays.

I shall very much appreciate your help.

Thankyou!

Thanks and appreciate your response.  All are immuno-assays (with different detection technology) and are 510K exempt. 

My question is whether we need to submit technical data (bench testing) to FDA for registration to FURLS. 

Can you please share any websites for registration in  Canada,Brazil & Mexico.

your help is much appreciated.

------------------------------
Tabassum Naqvi
Regulatory Affairs
Fremont CA
United StatesTabassum
------------------------------

Original Message:
Sent: 13-Jun-2020 07:23
From: Richard Vincins
Subject: 510K exempt assays

Hello Anon,

With limited information, not knowing the type of IA the answers to provide are not going to be so clear.  Plus your information is a bit confusing because you state writing a regulatory plan for a 510(k) Exempt device, but your first question is asking about a pathway for 510(k) Exempt of 510(k) submission.

1. The answer to this question really depends on the IA, the Product Code, and the Registration number.  If indeed the product is 510(k) Exempt, then you only need to register the product through the Medical Device Listing.  However, as you say a new 510(k) submission, so this would ask the question if you are changing the indication for use or something else that would no longer make it exempt.
2. Registration of a product is done through the Medical Device Listing page through a FURLS account: https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list.
3. Answer to this question depends on the IA, whether a 510(k) is required, and what type of performance testing is currently existing.  There are many factors going into whether comparative performance testing is required, but some assays indeed have comparison testing done as part of the analytical testing and performance testing.
4. Registration - medical device listing only takes a little time as this is done through the FURLS database.
5. See above.

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

Original Message:
Sent: 12-Jun-2020 10:27
From: Anonymous Member
Subject: 510K exempt assays

This message was posted by a user wishing to remain anonymous

Hi

I am writing up a regulatory plan for 510K exempt immunoassays with a new detection technology for launch of these assays in US, Canada, Brazil & Mexico.

The assays were previously cleared by FDA.

I have a few questions related to this:

1. What path to undertake for approval  or registration from FDA   (510 K exempt or new 510 K submission)
2. Procedure to register the assays on the FDA website
3. Would FDA like to see all the performance data in comparison to predicate
4.  Time lines for registration
5. which link should I use for registration of the new assays.

I shall very much appreciate your help.

Thankyou!