RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > Legislators Call for Publicly Available 510(k) Database to Address 'Loophole'

Legislators Call for Publicly Available 510(k) Database to Address 'Loophole'

Posted 20 August 2012 | By Alexander Gaffney, RAC 

Two legislators have written to the US Food and Drug Administration's (FDA) top medical device regulator, calling on the agency to provide for public access information about medical devices cleared through FDA's 510(k) premarket notification process.

The letter, sent 15 August by Rep. Edward Markey (D-MA) and Sen. Jeff Merkley (D-OR), observes that several medical devices once cleared through the 510(k) process have been subject to high-profile safety concerns and recalls in recent years. Devices cleared through the pathway are required to prove they are substantially equivalent to a device already approved by the agency, and are typically allowed to bypass clinical testing requirements.

Markey and Merkley said they were particularly concerned that medical devices since withdrawn from the market for safety reasons could still be used to form the basis of a substantial equivalence determination by the agency. The agency, noted the legislators, is required to approve such devices if they meet the statutory requirements for substantial equivalence.

Both Dr. Jeffery Shuren, director of the Center for Devices and Radiological Health (CDRH), and Markey have previously called for the closure of the pathway, with Shuren going as far as to call it a "loophole" in an interview with Bloomberg in February 2012. Markey has also sponsored legislation in the House to create a distinction between devices withdrawn from the market for reasons of economics and those withdrawn for safety reasons.

Public Information

While the legislation has been stalled in the House, the legislators are now calling on Shuren to release more information to the public in the meantime. "We also believe that providing device manufacturers, the public and medical professionals with better information about devices recalled for serious design flaws could help avoid future issues," the legislators wrote.

To accomplish this, they asked Shuren to release publicly whether a device was withdrawn for reasons of safety or effectiveness and whether the predicate device itself was cleared through the 510(k) pathway.

"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," Markey and Merkley wrote. Sponsors would have better information for conducting risk assessments, regulators could better target riskier devices and the public could be better informed about which devices likely pose the greatest risk to their health, they explained.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.