Webinar - ASCA Pilot: Streamlining Conformity Assessment in Device Submissions
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Webinar Materials
Summary
On May 20, 2021, the U.S. Food and Drug Administration (FDA) hosted a webinar to share information and answer questions about the Accreditation Scheme for Conformity Assessment (ASCA) Pilot.
Background
Under the ASCA Pilot, the FDA grants ASCA Recognition to qualified accreditation bodies to accredit testing laboratories to perform premarket testing for medical device companies.
During this webinar, the FDA:
- Shared strategies for successful participation in the ASCA Pilot.
- Explained how manufacturers should prepare premarket submissions for medical devices with testing from ASCA-accredited testing laboratories.
- Answered your questions about the ASCA Pilot.