Regulatory Open Forum

Hello community members!

Has anyone used the FDA's Third Party Review/Accredited Persons program before when submitting a 510(k)? 

I was looking at a report (attached) that showed a comparison in review times between FDA review and Third Party review (177 days and 49 days, respectively).  This seems like a large difference, yet I've read that the Third Party Review program is underutilized.  I realize a limited number of device types are eligible for the Third Party program - is it a recommended route to take if you are eligible?  

Any feedback or experiences with the program would be greatly appreciated!

Thank you in advance.

------------------------------
Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
------------------------------

Hi Brittany,

Yes, I've used a 3rd Party organization successfully.  FYI, FDA released the most recent 3rd party performance report on April 11th covering 2018 and the first 2 quarters of 2019, which can be viewed here: https://www.fda.gov/media/123049/download.  My experience is with the 3rd Party in the report that had the most favorable total review time (hint, hint), of which I have absolutely no financial or other affiliation.

My recommendation is that a 3rd Party may be used most successfully for devices that are close to being a me-too product to the one for which you wish to obtain 510(k) clearance.  This is as opposed to using a 3rd Party for a device with potentially significant technological differences from its predicate.  Basically, if it's a knock-off in terms of indications for use and technological characteristics to a previously cleared device, my opinion is that use of a 3rd Party represents a potentially significant time-to-clearance advantage.

This, of course, depends on the quality of the 510(k) submission to begin with.  I once was asked to resolve issues raised through two rounds of questions from a 3rd Party reviewer.  My review of the history of documentation was that the 3rd Party questions were completely justified.  It was clear that the original 510(k), and sponsor responses to the two rounds of questions, were poorly constructed. 

After interfacing with the reviewer and proposing precisely what was planned to resolve all deficiencies, executing the plan, and submitting what I hoped would be an articulate documentation package, a recommendation for 510(k) clearance was submitted by the 3rd party to the FDA within a week.  FDA clearance was obtained a couple of weeks later. 

Another potential tip is to use the FDA 510(k) database to determine which (if any) 3rd Party previously handled 510(k)s for devices with the same Product Code as that for your device.  For example, for diagnostic ultrasound imaging systems (Product Code IYO), you will find that a certain 3rd Party has handled over 400 cleared 510(k)s.  Using a 3rd Party with extensive knowledge of the various performance standards and FDA guidance documents may, in my opinion, represent a significant time savings.

Hope this helps.

If you require any additional information, please feel free to PM me.

All the best,

Kevin​

------------------------------
Kevin Daly
Kevin Daly Consulting, LLC
Encinitas CA
United States
------------------------------

Original Message:
Sent: 17-May-2019 17:54
From: Brittany Gibson
Subject: FDA Third Party Review

Hello community members!

Has anyone used the FDA's Third Party Review/Accredited Persons program before when submitting a 510(k)?

I was looking at a report (attached) that showed a comparison in review times between FDA review and Third Party review (177 days and 49 days, respectively).  This seems like a large difference, yet I've read that the Third Party Review program is underutilized.  I realize a limited number of device types are eligible for the Third Party program - is it a recommended route to take if you are eligible?

Any feedback or experiences with the program would be greatly appreciated!

Thank you in advance.

------------------------------
Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
------------------------------

Greetings Brittany,
Thank you for bringing this topic up. I have worked with Emergo in the past and while they are great at providing high-level info, they are not so great at the details. Sadly, the estimate provided and recommendation is based solely on the FDA review time. They did not account for the time the submission was under review with the actual third party before getting into FDA hands. The FDA will publish in the 510(k) database the date they received it from the 3rd party reviewer (with the reviewers recommendation to approve), then they publish the date of actual approval. So, ya, 49 days is expected given MDUFA commitments and review timelines published, but is incorrect. In the recent FY 2019 MDUFA performance summary, the average total time a 510k was reviewed by the third party was 107 days, followed by 41 days with FDA. Therefore, total time has averaged 134 days. It was 162 last fiscal year, so I expect this year's average to creep up and be close to last year. A realistic "time" savings will probably get you to launch 1 month sooner. 
If you do end up going the third party route I would love to hear from you directly on your experience. 

Regards,
Danni

------------------------------
Danielle Briggeman
Clinical & Regulatory Affairs Manager
Portland ME
United States
------------------------------

Original Message:
Sent: 17-May-2019 17:54
From: Brittany Gibson
Subject: FDA Third Party Review

Hello community members!

Has anyone used the FDA's Third Party Review/Accredited Persons program before when submitting a 510(k)?

I was looking at a report (attached) that showed a comparison in review times between FDA review and Third Party review (177 days and 49 days, respectively).  This seems like a large difference, yet I've read that the Third Party Review program is underutilized.  I realize a limited number of device types are eligible for the Third Party program - is it a recommended route to take if you are eligible?

Any feedback or experiences with the program would be greatly appreciated!

Thank you in advance.

------------------------------
Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
------------------------------

I agree, Danni. The estimates aren't a full accounting. The non-existent time clock has pros and cons. It's great if the applicant needs extra time to respond but it works both ways. The third-party reviewers aren't as prolifically staffed as FDA so you might have to wait. All applications under FDA review have priority so those move to the front of the queue regardless of how quickly you respond. A response to a round of questions could take up to two months before they are even able to look at it depending on their current workload. I do think it probably works best when there are virtually no differences between the new device and the predicate.

------------------------------
Ruthanne Vendy RAC
Senior Principal Specialist
United States
------------------------------

Original Message:
Sent: 20-May-2019 17:40
From: Danielle Briggeman
Subject: FDA Third Party Review

Greetings Brittany,
Thank you for bringing this topic up. I have worked with Emergo in the past and while they are great at providing high-level info, they are not so great at the details. Sadly, the estimate provided and recommendation is based solely on the FDA review time. They did not account for the time the submission was under review with the actual third party before getting into FDA hands. The FDA will publish in the 510(k) database the date they received it from the 3rd party reviewer (with the reviewers recommendation to approve), then they publish the date of actual approval. So, ya, 49 days is expected given MDUFA commitments and review timelines published, but is incorrect. In the recent FY 2019 MDUFA performance summary, the average total time a 510k was reviewed by the third party was 107 days, followed by 41 days with FDA. Therefore, total time has averaged 134 days. It was 162 last fiscal year, so I expect this year's average to creep up and be close to last year. A realistic "time" savings will probably get you to launch 1 month sooner.
If you do end up going the third party route I would love to hear from you directly on your experience.

Regards,
Danni

------------------------------
Danielle Briggeman
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 17-May-2019 17:54
From: Brittany Gibson
Subject: FDA Third Party Review

Hello community members!

Has anyone used the FDA's Third Party Review/Accredited Persons program before when submitting a 510(k)?

I was looking at a report (attached) that showed a comparison in review times between FDA review and Third Party review (177 days and 49 days, respectively).  This seems like a large difference, yet I've read that the Third Party Review program is underutilized.  I realize a limited number of device types are eligible for the Third Party program - is it a recommended route to take if you are eligible?

Any feedback or experiences with the program would be greatly appreciated!

Thank you in advance.

------------------------------
Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
------------------------------

I have used 3rd party review many times. In all cases it shaved at least 1-2 months off review. When I was at 3M, I trialed it in the Dental Division.  It became the norm for a while, and we had review times for example 6 days (yes, 6), 18 days, 34 days, 47 days, etc. for well known regulatory paths.  All of these were Traditional 510(k)s..   this was actual calendar days from submission to clearance. 


Some of the longer ones were more complex, or reviewers were asking for things not required but if the submission is well written and has good justification, it can be done very quickly.  The funny part is that it almost shot us in the foot because the business then always expected clearances extremely fast.  The other healthcare divisions started asked why the Dental Division (3M ESPE) had such quick clearances.  The business in that Division was willing to pay the extra $ for Third Party review. It made our KPIs look good.

Just choose your Third Party wisely. They need to have the experience in your device, and you can push back, as I have in certain items.


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

Original Message:
Sent: 20-May-2019 17:40
From: Danielle Briggeman
Subject: FDA Third Party Review

Greetings Brittany,
Thank you for bringing this topic up. I have worked with Emergo in the past and while they are great at providing high-level info, they are not so great at the details. Sadly, the estimate provided and recommendation is based solely on the FDA review time. They did not account for the time the submission was under review with the actual third party before getting into FDA hands. The FDA will publish in the 510(k) database the date they received it from the 3rd party reviewer (with the reviewers recommendation to approve), then they publish the date of actual approval. So, ya, 49 days is expected given MDUFA commitments and review timelines published, but is incorrect. In the recent FY 2019 MDUFA performance summary, the average total time a 510k was reviewed by the third party was 107 days, followed by 41 days with FDA. Therefore, total time has averaged 134 days. It was 162 last fiscal year, so I expect this year's average to creep up and be close to last year. A realistic "time" savings will probably get you to launch 1 month sooner.
If you do end up going the third party route I would love to hear from you directly on your experience.

Regards,
Danni

------------------------------
Danielle Briggeman
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 17-May-2019 17:54
From: Brittany Gibson
Subject: FDA Third Party Review

Hello community members!

Has anyone used the FDA's Third Party Review/Accredited Persons program before when submitting a 510(k)?

I was looking at a report (attached) that showed a comparison in review times between FDA review and Third Party review (177 days and 49 days, respectively).  This seems like a large difference, yet I've read that the Third Party Review program is underutilized.  I realize a limited number of device types are eligible for the Third Party program - is it a recommended route to take if you are eligible?

Any feedback or experiences with the program would be greatly appreciated!

Thank you in advance.

------------------------------
Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
------------------------------

My experience has been similar - at times there have been rounds of 3rd party questions and THEN FDA basically re-reviewed the submission, leading to no real time improvement overall (but a cost increase). That said, I agree with a previous poster that it depends on what type of product and how many of those products the 3rd party has done. There are some 510(k)s that are fairly straight-forward and likely work well - but not all products eligible for 3rd party review are ideal for such.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 20-May-2019 17:40
From: Danielle Briggeman
Subject: FDA Third Party Review

Greetings Brittany,
Thank you for bringing this topic up. I have worked with Emergo in the past and while they are great at providing high-level info, they are not so great at the details. Sadly, the estimate provided and recommendation is based solely on the FDA review time. They did not account for the time the submission was under review with the actual third party before getting into FDA hands. The FDA will publish in the 510(k) database the date they received it from the 3rd party reviewer (with the reviewers recommendation to approve), then they publish the date of actual approval. So, ya, 49 days is expected given MDUFA commitments and review timelines published, but is incorrect. In the recent FY 2019 MDUFA performance summary, the average total time a 510k was reviewed by the third party was 107 days, followed by 41 days with FDA. Therefore, total time has averaged 134 days. It was 162 last fiscal year, so I expect this year's average to creep up and be close to last year. A realistic "time" savings will probably get you to launch 1 month sooner.
If you do end up going the third party route I would love to hear from you directly on your experience.

Regards,
Danni

------------------------------
Danielle Briggeman
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 17-May-2019 17:54
From: Brittany Gibson
Subject: FDA Third Party Review

Hello community members!

Has anyone used the FDA's Third Party Review/Accredited Persons program before when submitting a 510(k)?

I was looking at a report (attached) that showed a comparison in review times between FDA review and Third Party review (177 days and 49 days, respectively).  This seems like a large difference, yet I've read that the Third Party Review program is underutilized.  I realize a limited number of device types are eligible for the Third Party program - is it a recommended route to take if you are eligible?

Any feedback or experiences with the program would be greatly appreciated!

Thank you in advance.

------------------------------
Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
------------------------------

My experience with 3rd party review has not always been so favorable. The most recent one I worked on we ultimately decided to just drop the 3rd party pathway and submit directly to FDA.  (In my defense I told my client that I didn't think the 3rd party review would save him any time due to the technological differences...but saying "I told you so" in consulting never feels good to anyone.)  The files that go through this route (i.e. drop it and just go to FDA) are unlikely captured by those review time assessments as they would blow the numbers away. 

I think the previous writers are all spot on and I want to echo Kevin's comment that the program "may be used most successfully for devices that are close to being a me-too product."  FDA wants to promote this pathway and remove some of the burden they're facing with file load.  But I believe it should be used cautiously and you definitely want to evaluate the different review parties to make sure you have one that can confidently review your file.  Speaking of, be careful on mistaking the Accredited Person's 'desire to get your business' with 'confidence' as I've twice had parties tell my clients "we're perfect for your device and can shave X number of days off of your review time!"  That sounded too good to be true and it was.  Do your own research in the FDA databases on how many files under that pro code they've helped get successfully through FDA.  Then do the math to see if FDA had to 're-review' like Ginger mentioned, or if they essentially went along with that party's SE recommendation.  You should be able to do this by looking at the 'receipt' and 'clearance' dates in the summaries.   

------------------------------
Allison Komiyama RAC, PhD
Principal, Regulatory Affairs
San Diego CA
United States
------------------------------

Original Message:
Sent: 21-May-2019 11:02
From: Ginger Glaser
Subject: FDA Third Party Review

My experience has been similar - at times there have been rounds of 3rd party questions and THEN FDA basically re-reviewed the submission, leading to no real time improvement overall (but a cost increase). That said, I agree with a previous poster that it depends on what type of product and how many of those products the 3rd party has done. There are some 510(k)s that are fairly straight-forward and likely work well - but not all products eligible for 3rd party review are ideal for such.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 20-May-2019 17:40
From: Danielle Briggeman
Subject: FDA Third Party Review

Greetings Brittany,
Thank you for bringing this topic up. I have worked with Emergo in the past and while they are great at providing high-level info, they are not so great at the details. Sadly, the estimate provided and recommendation is based solely on the FDA review time. They did not account for the time the submission was under review with the actual third party before getting into FDA hands. The FDA will publish in the 510(k) database the date they received it from the 3rd party reviewer (with the reviewers recommendation to approve), then they publish the date of actual approval. So, ya, 49 days is expected given MDUFA commitments and review timelines published, but is incorrect. In the recent FY 2019 MDUFA performance summary, the average total time a 510k was reviewed by the third party was 107 days, followed by 41 days with FDA. Therefore, total time has averaged 134 days. It was 162 last fiscal year, so I expect this year's average to creep up and be close to last year. A realistic "time" savings will probably get you to launch 1 month sooner.
If you do end up going the third party route I would love to hear from you directly on your experience.

Regards,
Danni

------------------------------
Danielle Briggeman
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 17-May-2019 17:54
From: Brittany Gibson
Subject: FDA Third Party Review

Hello community members!

Has anyone used the FDA's Third Party Review/Accredited Persons program before when submitting a 510(k)?

I was looking at a report (attached) that showed a comparison in review times between FDA review and Third Party review (177 days and 49 days, respectively).  This seems like a large difference, yet I've read that the Third Party Review program is underutilized.  I realize a limited number of device types are eligible for the Third Party program - is it a recommended route to take if you are eligible?

Any feedback or experiences with the program would be greatly appreciated!

Thank you in advance.

------------------------------
Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
------------------------------

I would echo Allison's experience.  I would especially recommend going directly to FDA if the company is not well established with multiple products in their portfolio.  Filing for a "first ever" device via third-party can be tricky.  Not so tricky if the company is only making modifications to an existing, already cleared device.

If you want to know what the REAL review times are, you have to look elsewhere on FDA's webpage.  Review time performance is not reflected in the usual 510(k) database.  If you want to see performance measures, you need to look here - https://www.fda.gov/about-fda/cdrh-transparency/third-party-performance-metrics.  This page will give you more details about the performance of each 3rd party review organization.

Cheers,

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

Original Message:
Sent: 22-May-2019 06:02
From: Allison Komiyama
Subject: FDA Third Party Review

My experience with 3rd party review has not always been so favorable. The most recent one I worked on we ultimately decided to just drop the 3rd party pathway and submit directly to FDA.  (In my defense I told my client that I didn't think the 3rd party review would save him any time due to the technological differences...but saying "I told you so" in consulting never feels good to anyone.)  The files that go through this route (i.e. drop it and just go to FDA) are unlikely captured by those review time assessments as they would blow the numbers away.

I think the previous writers are all spot on and I want to echo Kevin's comment that the program "may be used most successfully for devices that are close to being a me-too product."  FDA wants to promote this pathway and remove some of the burden they're facing with file load.  But I believe it should be used cautiously and you definitely want to evaluate the different review parties to make sure you have one that can confidently review your file.  Speaking of, be careful on mistaking the Accredited Person's 'desire to get your business' with 'confidence' as I've twice had parties tell my clients "we're perfect for your device and can shave X number of days off of your review time!"  That sounded too good to be true and it was.  Do your own research in the FDA databases on how many files under that pro code they've helped get successfully through FDA.  Then do the math to see if FDA had to 're-review' like Ginger mentioned, or if they essentially went along with that party's SE recommendation.  You should be able to do this by looking at the 'receipt' and 'clearance' dates in the summaries.   

------------------------------
Allison Komiyama RAC, PhD
Principal, Regulatory Affairs
San Diego CA
United States

Original Message:
Sent: 21-May-2019 11:02
From: Ginger Glaser
Subject: FDA Third Party Review

My experience has been similar - at times there have been rounds of 3rd party questions and THEN FDA basically re-reviewed the submission, leading to no real time improvement overall (but a cost increase). That said, I agree with a previous poster that it depends on what type of product and how many of those products the 3rd party has done. There are some 510(k)s that are fairly straight-forward and likely work well - but not all products eligible for 3rd party review are ideal for such.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 20-May-2019 17:40
From: Danielle Briggeman
Subject: FDA Third Party Review

Greetings Brittany,
Thank you for bringing this topic up. I have worked with Emergo in the past and while they are great at providing high-level info, they are not so great at the details. Sadly, the estimate provided and recommendation is based solely on the FDA review time. They did not account for the time the submission was under review with the actual third party before getting into FDA hands. The FDA will publish in the 510(k) database the date they received it from the 3rd party reviewer (with the reviewers recommendation to approve), then they publish the date of actual approval. So, ya, 49 days is expected given MDUFA commitments and review timelines published, but is incorrect. In the recent FY 2019 MDUFA performance summary, the average total time a 510k was reviewed by the third party was 107 days, followed by 41 days with FDA. Therefore, total time has averaged 134 days. It was 162 last fiscal year, so I expect this year's average to creep up and be close to last year. A realistic "time" savings will probably get you to launch 1 month sooner.
If you do end up going the third party route I would love to hear from you directly on your experience.

Regards,
Danni

------------------------------
Danielle Briggeman
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 17-May-2019 17:54
From: Brittany Gibson
Subject: FDA Third Party Review

Hello community members!

Has anyone used the FDA's Third Party Review/Accredited Persons program before when submitting a 510(k)?

I was looking at a report (attached) that showed a comparison in review times between FDA review and Third Party review (177 days and 49 days, respectively).  This seems like a large difference, yet I've read that the Third Party Review program is underutilized.  I realize a limited number of device types are eligible for the Third Party program - is it a recommended route to take if you are eligible?

Any feedback or experiences with the program would be greatly appreciated!

Thank you in advance.

------------------------------
Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
------------------------------