The GAO report on the 510(k) process

A

Adele

#1
What do people think of the GAO report on the 510(k) process?

I am slightly disappointed. After all the promise and expectation that it would “shake-up” the 510(k) process, it has under-delivered. What happened to the rumours that it would lead to the creation of another Class, increased data requirements for 510(k) submissions, and increased evaluation time?

By focusing this report has been on Class III devices that are able to be cleared through the 510(k) process (rather than the PMA process), the GAO has taken the easy path. Instead of using this as an opportunity to challenge the status quo and consider alternatives, the report has focused on 1 colour from the bigger picture.

Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. GAO-09-190, January 15. http://www.gao.gov/cgi-bin/getrpt?GAO-09-190
 
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M

MIREGMGR

#3
(Note that this is really an FDA, not 13485/MDD, thread.)

The GAO report focused on risk, which is theoretically logical but doesn't correspond to how devices are sorted (edit: by the FDA) for regulatory purposes, primarily because risk is both subjective and not apparent when a new-technology/new-intended-use device is first presented for categorization.

The FDA's response to date...all new-technology/new-intended-use devices will be required to go the PMA route...will be wildly unacceptable from a political perspective, since it will impose on the small-business and entrepreneurial stratum of the medical device world--where most device technology advancements occur--the very high hurdle of the $250,000-and-upward cost and very long timeline of the PMA process, even if the device in question subjectively entails low risks.

Perhaps in announcing that new policy, the FDA's current keepers were trying to appear immediately responsive and also get the politically-radioactive stuff done before the new Commissioner comes on board, so that he or she can take credit for "fixing the situation the correct way."

It appears to me that the only viable FDA path is a much greater focus on risk as a means of initial device classification.

Given that the GAO report arose out of too many device makers having routed high-risk devices through the low-risk regulatory approval pipeline and not being caught, I don't think anyone at FDA considers as a realistic solution the 13485/MDD approach of trusting device makers' judgement calls as to whether they are properly presenting a low risk device.

Thus it seems that some means of risk verification at the beginning of the regulatory process, external to the device marketers and structured to be responsible to the FDA rather than to their customers, will be needed. I don't know how that will be made to work.
 
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