dangerous loophole, Database, Ed Markey, FDA, Federal Food Drug and Cosmetic Act, Food & Drug Administration, Jeffrey Shuren, Massachusetts, Medical device, premarket notification, science, Technology
Dems urge FDA to boost medtech recall database | MassDevice.com On Call
August 17, 2012 by MassDevice staff
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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