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Experts: MDR Draft Guidance Compiles Advice, Seeks More Info From Firms

This article was originally published in The Silver Sheet

Executive Summary

While much of the information found in FDA’s new 47-page draft guidance for Medical Device Reporting can be found in the MDR regulation, it nevertheless compiles a wealth of advice that the agency has doled out over a number of years.

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FDA’s Quest For More MDR Exemption Requests Leaves Device Industry Jittery

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.

FDA’s Quest For More MDR Exemption Requests Leaves Device Industry Jittery

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.

Draft Guidance Tackles Common Errors In Adverse Event Reporting

A revised guidance on medical device reporting fleshes out FDA’s thinking on manufacturers’ responsibilities in various situations.

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