A duo of Democrats urge the FDA to "overhaul and streamline" recall and 510(k) databases to ensure new products aren't winning clearance on flawed designs.
MASSDEVICE ON CALL — Congressmen Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkely (D-Ore.) called on the FDA to "overhaul and streamline" its recalls and 510(k) premarket notification database.
The legislators want the FDA to ensure that the data is "publicly available and easily searchable" so that it better serves the needs of medical device reviewers, manufacturers and patients, according to a letter they jointly issued to FDA medical devices director Dr. Jeffrey Shuren.
"Current law requires FDA to clear a device shown to be substantially equivalent to a predicate, even in cases where the new product contains the same flaws as an earlier model," the pair wrote. "Database improvements would enhance the transparency of the 510(k) process and help manufacturers avoid using recalled devices as predicates that may put their own devices at risk for future enforcement action."