The U.S. FDA has recognized the ANSI National Accreditation Board (ANAB), a wholly owned subsidiary of the American National Standards Institute (ANSI), as an accreditation body for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot. The FDA recognition allows ANAB to accredit testing laboratories to perform premarket testing for medical device companies.

The voluntary ASCA pilot is intended to increase consistency and predictability in the FDA’s approach to assessing conformance with FDA-recognized consensus standards and test methods for medical devices. The pilot is also intended to enhance product reviewers’ and device manufacturers’ confidence in medical device testing. This, in turn, should decrease the need for the FDA to request additional information about testing methodologies when a premarket submission includes declarations of conformity to an FDA-recognized consensus standard eligible for inclusion in the ASCA pilot.

“ANAB’s participation in the ASCA pilot is consistent with our mission to provide accreditation processes that build confidence and provide value for stakeholders,” says Jason Stine, ANAB senior director of accreditation. “We look forward to supporting the FDA’s goal of helping ensure patients have timely access to safe, effective, and high-quality medical devices.”

The ASCA pilot relies on international conformity assessment standards and a set of FDA-identified ASCA program specifications. The program includes both cross-cutting and device-specific standards. Reflecting the comprehensiveness of the program, the FDA selected standards and tests from the biocompatibility series and the basic safety and essential performance series, all of which have public health significance and provide the means for establishing acceptance criteria. ANAB’s scope of ASCA pilot recognition includes the full array of ASCA pilot standards.

Participants in the pilot include accreditation bodies (such as ANAB), ISO/IEC 17025 testing laboratories, medical device manufacturers, and FDA staff. Moreover, manufacturers fund the pilot program through the FDA’s Medical Device User Fee Amendments of 2017 User Fee program. There is no additional fee for manufacturers to participate in the pilot, nor does the FDA charge a fee for accreditation bodies or laboratories participating in the pilot.