FDA Issues Draft Guidance on Accreditation Scheme for Conformity Assessment (ASCA) Pilot

Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance entitled The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. This draft guidance introduces a pilot for a new conformity assessment program called the Accreditation Scheme for Conformity Assessment, or ASCA. In accordance with amendments made to section 514 of the Federal Food, Drug and Cosmetic Act by the FDA Reauthorization Act of 2017, and as part of the enactment of the Medical Device User Fee Amendments of 2017, this voluntary pilot program is designed to:  Reduce regulatory burden by enhancing confidence in certain medical device testing; and  Increase consistency and predictability in FDA’s approach to assessing conformance to ASCA-eligible standards and promote efficiencies in the device review process. The draft guidance introduces the ASCA Pilot and proposes expectations for accreditation bodies, testing laboratories, and manufacturers that wish to participate in the Pilot. The comment period for the draft guidance will be open under docket FDA-2019-D-3805 for (90) days.   Note that a review of the FDA’s Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices guidance may be helpful in evaluating the ASCA Pilot draft guidance and preparing comments.

Read the Draft Guidance Upcoming Webinar for Industry On October 28, 2019, the FDA will host a webinar for manufacturers, accreditation bodies, testing labs, standards organizations and others interested in learning more about this draft guidance and the ASCA Pilot. Questions?  If you have questions about this draft guidance, contact ASCA@fda.hhs.gov.