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

The voluntary ASCA Pilot 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 Pilot 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 Pilot.

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

The 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. 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 Pilot Documents and Information

Laboratories interested in attaining accreditation can request a quote or call ANAB at 414-501-5494. If you're already accredited to ISO/IEC 17025, you may be able to become accredited for the ASCA Pilot via scope extension.

Program Documents

SR 2437, Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment

SR 2438, Biocompatibility Testing of Medical Devices

FA 2004, Application for 17025 and ASCA Accreditation

MA 2100, Accreditation Manual

AR 2250, Accreditation Requirements - 17025 Testing Laboratories