CDRH Posts Update on Medical Device Testing Accreditation Pilot

The FDA posted an update on its Accreditation Scheme for Conformity Assessment (ASCA) pilot, which aims to streamline conformity assessments for medical device submissions that meet yet-to-be-announced standards.

The pilot will include “a minimum of five appropriate FDA-recognized consensus standards, at least one of which will be device-specific,” according to a new ASCA Q&A web page. The standards could include biological evaluation of medical devices and basic safety and essential performance of medical electrical equipment, medical electrical systems and laboratory equipment, according to the document.

During negotiations with industry stakeholders, a consensus emerged that an accreditation program could improve device premarket review, especially standards conformity assessment activities, the agency said.

Under the program, the FDA will define a conformity assessment scheme describing the interactions between and specifications for accreditation bodies and testing labs. The scheme will outline a process for participation by accreditation bodies and testing labs and for the suspension or withdrawal of poorly performing participants.

The agency also said it plans to post public information about ASCA testing labs, including the FDA-recognized consensus standards for which they are accredited, on its website.

In a video released at an ASCA workshop earlier this year, CDRH standards management staff member Scott Colburn said that many testing labs weren’t part of the standards development process—but now they can be. That way, “when we receive that test report, we have greater confidence in knowing that what the design of that standard was for can be met with what our perspective was when developing it,” he said.

As plans for the ASCA pilot move forward, stakeholders will have more opportunities to provide feedback. The agency says it will publish and seek comments on draft guidance by the end of FY 2019.

That guidance will include more specific information about participation in and operation of the program, which is slated to go into effect by September 30, 2020 — although in the new Q&A the agency says it’s “working to do so as soon as possible and before that date.”

Read the agency’s update here: www.fdanews.com/11-01-18-ASCA.pdf. — Gienna Shaw