FDA Draft Guidance Outlines Proposed Details of ASCA Pilot

Posted September 25, 2019

The Food and Drug Administration (FDA) released a draft guidance outlining a pilot program designed to accredit third party testing laboratories for premarket review of medical devices. The guidance document defines the role of and participation criteria for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot’s accreditation bodies, test laboratories, and device manufacturers.

The voluntary program is aimed at helping the agency “ensure safe, effective, and high-quality medical devices that are available to patients without avoidable delay,” said the agency. The concept originated from the FDA’s discussions with device manufacturers and other stakeholders documented in the 2017 Medical Device User Fee Amendments (MDUFA IV).

The ASCA pilot program "relies upon significant input from experts and is the result of a collaborative effort by the FDA, medical device industry and the conformity assessment community, which includes accreditation bodies and testing laboratories," said Scott A. Colburn, director of the Standards and Conformity Assessment Program in the FDA’s Center for Devices and Radiological Health, in a statement. “The program is another step intended to advance regulatory science in a way that could help ensure safe, effective and high-quality medical devices are available to patients while reducing unnecessary delays.”

The draft guidance serves as the agency’s response to its agreement with industry to increase its consistency and predictability when assessing premarket applications by accrediting testing laboratories to evaluate medical devices based on FDA-recognized consensus standards. In addition, the guidance explains how manufacturers can use test results from the Pilot Program and how FDA staff will consider these results if they are included in premarket submissions for medical devices.

“We look forward to the FDA’s ASCA Program. It is our belief that this process will support reduction in number of questions, consistency in FDA’s review, and increased partnership with stakeholders throughout the total product life cycle,” said Elisabeth George, head of government affairs, standards, and regulations at Philips. “All should engage in the Pilot whether it be just to share your thoughts or to jump into the deep end as a part of the process. Doing this will support longer term improvement in standards development, conformity assessment strategy, and time to market.”

The FDA is accepting comments on the draft guidance at www.regulations.gov until Dec. 23 (docket number FDA-2019-D-3805). The pilot is expected to launch no later than September 30, 2020.

The FDA is also offering an Oct. 28 webinar for discuss the ASCA program with industry, accreditation bodies, testing laboratories, and standards developing organizations.