News In Brief
This article was originally published in The Silver Sheet
Executive Summary
Firms don’t want FDA to remove “two-year rule” from MDR guidance; Medical Device Single Audit Program audits likely to start in June; and more.
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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 ISO Audit Program Chugs Along; May Be Absorbed By IMDRF Single-Audit Initiative
Thirty manufacturers have used FDA’s ISO 13485 voluntary audit program since the two-year pilot began last June, freeing up scarce agency inspectional resources to be used elsewhere. However, it will likely be eventually absorbed by a pilot Medical Device Single Audit Program currently under development by the International Medical Device Regulators Forum.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.