Wednesday, May 19, 2021

Webinar: The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions

Join us tomorrow May 20, for a webinar to learn how to prepare premarket submissions with ASCA testing, get updates on biocompatibility, and

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Reminder: Join Us Tomorrow for a Webinar on the ASCA Pilot: Streamlining Conformity Assessment in Device Submissions

The U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about the Accreditation Scheme for Conformity Assessment (ASCA) Pilot. 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.

  • Date: Thursday, May 20, 2021
  • Time: 2:30 to 4:00 p.m. ET
  • Registration: No registration required. The FDA encourages all interested stakeholders to join the webinar. View webinar details for call-in information.

View the Webinar Details

During this webinar, the FDA will:

  • Share strategies for successful participation in the ASCA Pilot.
  • Explain how manufacturers should prepare premarket submissions for medical devices with testing from ASCA-accredited testing laboratories.
  • Answer your questions about the ASCA Pilot.

Questions?

If you have questions about the ASCA Pilot, contact the Division of Industry and Consumer Education.


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