FDA Issues Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Final Guidances

Today, the U.S. Food and Drug Administration (FDA) issued three final guidance documents related to the Accreditation Scheme for Conformity Assessment Pilot Program (ASCA Pilot). These guidance documents outline the goals and implementation of the voluntary ASCA Pilot, intended to increase confidence in testing results from ASCA-accredited testing laboratories for certain FDA-recognized standards. Ultimately, the ASCA Pilot is expected to help the FDA ensure safe, effective, and high-quality medical devices are available to patients without unnecessary delay.

The three guidances are:

Program Guidance: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
Basic Safety and Essential Performance Standards-specific Guidance: Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
Biocompatibility Standards-specific Guidance: Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

Read the Guidances

Upcoming webinar on these guidances

On October 22, 2020, the FDA will host a webinar for industry, accreditation bodies, testing laboratories, and others interested in learning more about the guidances.