Should FDA implement 3rd party (PMAs) reviews? What are the pros and cons of doing so

E

endlesslovehv

#1
Unlike the 510(k), currently 3rd party review is not available for PMAs. Should FDA implement 3rd party reviews? What are the pros and cons of doing so?
 
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Doug Tropf

Quite Involved in Discussions
#2
Re: Should FDA implement 3rd party (PMAs) reviews? What are the pros and cons of doin

One "pro" is avoiding unexpected FDA visits. A "con" is the cost involved with 3rd party reviews.
 

yodon

Staff member
Super Moderator
#3
Re: Should FDA implement 3rd party (PMAs) reviews? What are the pros and cons of doin

I don't think that FDA using 3rd party reviewers would preclude them from visiting (unannounced) if they chose. They'd still be the big dog!

I think the biggest issue would be their liability. There's already plenty of heat on the FDA given the recent issues with infusion pumps, etc. According to some reports I've read, even 510(k)s are taking longer for approval despite fewer submissions. I think this says that the FDA is focusing more on the details - which would seemingly be the opposite of farming out PMA reviews.

As Doug points out, cost would also be an issue. But also consider how that cost is covered. Right now, FDA collects fees from device makers. I presume that doesn't completely cover their costs so the rest must be supplemented by tax $$. Increasing either would not be desirable.

I was thinking of putting this on the 'pro' side then thought about the issues. It's possible that reviewers with greater expertise could be assembled for the review. But then I got to thinking where they would come from. There's the chance of exposing IP or reviewer bias based on the submitting company.

Interesting question.
 
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