Congressional lawmakers expressed concern with a flaw in an FDA regulatory process that expedites approval of medical devices similar to previously approved devices. A law requires the FDA to clear a device substantially similar to a predicate, even if the the updated model contains the same design flaws that caused the earlier model to be recalled.
Rep. Edward J. Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) suggested to FDA's Center for Devices and Radiological Health Director Jeffrey Shuren, MD, JD, that the Recalls and 510(k) Premarket Notification databases be overhauled and streamlined to provide easily searchable information on device safety to the public.
“These 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 actions,” they wrote in an Aug. 15 letter. “These changes would also enhance awareness among the public and medical professionals of the potential dangers of medical devices that are based on flawed predicates.”
The legislators also asked for a response from Shuren by Sept. 19.