FDA Accreditation Scheme for Conformity Assessment (ASCA)

What is FDA Accreditation Scheme for Conformity Assessment (ASCA)?

ANAB provides accreditation for the U.S. Food and Drug Administration Accreditation Scheme for Conformity Assessment (ASCA) program as an FDA-recognized accreditation body.

The voluntary ASCA program is intended to increase consistency and predictability in the FDA’s approach to assessing conformance with FDA-recognized consensus standards and test methods. Thus, the ASCA program should enhance product reviewers’ and device manufacturers’ confidence in medical device testing.

This, in turn, is intended to 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 program.

Ultimately, the program is designed to help ensure patients have timely access to safe, effective, and high-quality medical devices.

The ASCA program 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. The FDA selected standards and tests from the biocompatibility and basic safety and essential performance series. The standards have public health significance and have or are able to provide the means for establishing acceptance criteria.

Access FDA ASCA Documents and Information

If you’re already accredited to ISO/IEC 17025, you may be able to become accredited for the ASCA program via scope extension.