FDA’s Quest For More MDR Exemption Requests Leaves Device Industry Jittery
• By Shawn M. Schmitt
A draft Medical Device Reporting guidance from FDA has concerned industry experts who say the document would require manufacturers to spend an onerous amount of time submitting requests for exemption to the agency’s MDR regulation. The draft removes a longstanding so-called “two-year rule” for reporting, calls for firms and contract manufacturers to jointly seek exemptions, and asks companies to file an exemption request after selling a 510(k). Close observers suggest the agency is proposing the modifications to make it clearer to agency investigators and companies when MDRs are in fact required. FDA also likely wants to maximize the useful post-market information it receives rather than cutting off MDR reports superficially, outside attorneys explain. But some experts argue the increased emphasis on exemptions would add more burden to companies and FDA with little benefit.
Manufacturers would have to file a flurry of requests to exempt themselves from Medical Device Reporting obligations if FDA finalizes a draft guidance that aims to tighten the agency’s reins on MDR activities, legal experts say.
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Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
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