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."
Ultimately the lawmakers hope to see the FDA gain the authority to reject medical devices which rely on recalled devices as predicates, but in the meantime hope that making recall data more accessible and transparent will "enhance awareness among the public and medical professionals of the potential dangers of medical devices that are based on flawed predicates," according to the letter.
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