Choice of FDA reviewer

primavesvera

Involved In Discussions
#1
I would like to start a discussion and to see what are your experiences regarding the FDA reviewers and their team.

For example, for the first device, we got a great reviewer, it was really easy working with him.

We did a few Q-Subs, also great cooperation.

However, recently we have been getting the same reviewer for a couple of products, and things are not going so great.

I wonder how they decide who will get the product for the review if they give it to the same reviewer because of the familiarity with the company or is there something else?

Your answers will be appreciated.

Cheers!
 
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Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#2
My experience is the FDA tries to keep the same reviewers with devices. Our current reviewer is very unresponsive but we take that as a good thing since our 60 day period for our 510(k) is coming up in a week.
 

primavesvera

Involved In Discussions
#3
My experience is the FDA tries to keep the same reviewers with devices. Our current reviewer is very unresponsive but we take that as a good thing since our 60 day period for our 510(k) is coming up in a week.
Ed, thanks for the response.

We were hoping for the same outcome, but then, a couple of days prior to the 90-days period, we got an additional information request. I hope it doesn't happen to you as well. :)
 

Watchcat

Trusted Information Resource
#4
Some reviewers are "better" than others. Some reviewers and companies are better fits than others. Plus, we are in the middle of a pandemic and FDA is in the middle of a political firestorm. It already advised industry it can't commit to MDUFA timelines. Your previous reviewer may have been overloaded at the time your submission came in. Do you know if they are still with the FDA? Still in the same position?
 

Watchcat

Trusted Information Resource
#5
My experience is the FDA tries to keep the same reviewers with devices.
Same devices yes, but my read is that this is not the same device, but other devices, same company. My experience is that you will often be assigned different reviewers for different devices. I think this is because reviewers are usually assigned to submissions, not to companies.
 

primavesvera

Involved In Discussions
#6
Some reviewers are "better" than others. Some reviewers and companies are better fits than others. Plus, we are in the middle of a pandemic and FDA is in the middle of a political firestorm. It already advised industry it can't commit to MDUFA timelines. Your previous reviewer may have been overloaded at the time your submission came in. Do you know if they are still with the FDA? Still in the same position?
Oh, the first encounter was in the pre-pandemic world. :)
It was for one product, software-based, but we continued to get the same reviewer, even if it's not the same product anymore (it's still a software, though).
 

mihzago

Trusted Information Resource
#7
I've had the same reviewer for the last 2 submissions but for one I recently sent have a new one, so it's hard to say who you'll get.

As others have said, FDA assigns based on availability, but possibly also to train reviewers on different devices. Attrition rates at the FDA are pretty high.
 
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