Sen. Markey Applauds CDRH Database Improvements
This article was originally published in The Gray Sheet
The Democratic senator from Massachusetts, highly critical of the potential for a device to be FDA-cleared with a predicate that has been recalled for safety issues, says he supports recent changes made by FDA’s device center to its recalls, 510(k) and PMA databases.
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Jay Crowley, the principle architect of FDA’s UDI regulation, is leaving the agency. FDA announced the launch of a website tracking the reclassification of device types, the accreditation GS1 as a UDI issuing agency and improvements to its device recalls database. More regulatory news.
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Sponsors say the bill “closes a significant loophole that currently puts patients at serious risk of debilitating injury by ensuring that devices do not mimic the mistakes made by other products.”