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Sen. Markey Applauds CDRH Database Improvements

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.

FDA’s device center made several upgrades to its recalls database last month, and at least one device industry critic in Congress, Sen. Edward Markey, D-Mass., is heartened by the changes.

On Dec. 16, CDRH expanded its recalls database to include whether a recall has been terminated, and to list product codes and pre-market submission numbers associated with a recall. In...

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• By Shubham Singh

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