Congressional Dems want FDA to reform 510(k) process

Taking up where consumer groups left off, two congressional Democrats are looking to make it harder for devicemakers to market devices based on recalled techs.

In a letter to the FDA, Rep. Edward Markey (D-MA) and Sen. Jeff Merkley (D-OR) asked the agency to reform its database and allow physicians and patients to keep tabs on techs that get 510(k) clearance by reimagining on faulty forebears. The congressmen asked the agency to make clear which devices were based on recalled predecessors and include information on the design flaws that led to recalls.

"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 action," the two write to FDA device boss Dr. Jeffrey Shuren. "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."

There is a pending bill in the House that would allow the FDA to reject a 510(k) app based on a recalled device--called the Safety of Untested and New Devices Act, or SOUND Act, in keeping with Congress' acronymic affinity--but the legislation hasn't gone anywhere since being introduced in February.

Back in the run-up to Congress' approval of new FDA user fees, watchdogs, like Consumers Union, lobbied for 510(k) reform to be written into the FDA Safety and Innovation Act. The bill, however, sailed through Congress and onto President Barack Obama's desk without any such language.

- read Markey and Merkley's statement
- here's their letter to Shuren (PDF)

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