With Eye on Medical Devices, FDA to Develop Accreditation System for Testing Labs


Posted May 17, 2017

With a new set of Medical Device User Fee Amendments (MDUFA IV) making their way through Congress, the Food and Drug Administration (FDA) is getting a jump-start on a plan to recognize accredited testing laboratories. Under this scheme, the agency would use reports from these laboratories during premarket reviews as evidence of conformity to recognized standards by manufacturers.

The agency is asking for feedback on its proposal, which it outlined in a Federal Register notice published May 16.

Under the current system, medical device manufacturers can include a “Declaration of Conformity” to identify which voluntary consensus standards they used in their application to meet premarket requirements for their devices. According to the FDA, this system “has not been consistently applied by sponsors in submissions,” causing “challenges for manufacturers and FDA alike.”

“Inconsistent testing creates inconsistent review practices,” said Scott Colburn, director of the standards program at the FDA’s Center for Devices and Radiological Health, at last month’s Symposium on the Evolving Standards and Regulatory Structure for Medical Devices.

During their MDUFA negotiations, the FDA and device manufacturers agreed to establish an Accreditation Scheme for Conformity Assessment (ASCA) that would recognize accredited testing laboratories to evaluate medical devices according to certain FDA-recognized standards.

“This initiative will benefit sponsors of submissions who can have the tests conducted at recognized accredited test labs and submit to FDA a determination from the test laboratory that their device conforms to the standards tested,” the FDA wrote in the Federal Register notice. “Once developed, the ASCA will ease a regulatory burden on industry by allowing them to use recognized accredited test laboratories to ensure accurate conformance with the consensus standard.”

According to Colburn, the FDA is planning to build this scheme around performance-based standards that include consistent and repeatable test methods, procedures, and criteria; work horizontally across devices; and can apply to a large number of manufacturers in a device area.

The agency is interested in industry feedback on which FDA-recognized consensus standards need to be included to get manufacturers to participate in the program, as well as other “insight regarding the development and overall design/approach of the ASCA pilot program.” Comments can be submitted via www.regulations.gov until June 30.

If the user-fee agreement is reauthorized as written, the HHS secretary must hold a public meeting on the ASCA public program by early next fall, with the program launching by Sept. 30, 2020.