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Webinar Materials

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Summary

On October 22, 2020, the FDA hosted a webinar for the medical device industry and other stakeholders to discuss and answer questions about three final guidance documents related to the Accreditation Scheme for Conformity Assessment Pilot Program (ASCA Pilot): Program Guidance, Basic Safety and Essential Performance Standards-specific Guidance, and Biocompatibility Standard-specific Guidance

Background

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 and 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