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  5. Webinar - Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance - 10/28/2019 - 10/28/2019
  1. Workshops & Conferences (Medical Devices)


Event Title
Webinar - Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance
October 28, 2019

October 28, 2019
12:00 PM - 01:30 PM EDT
Organized By:

Summary: On October 28, 2019, the FDA will host a webinar for industry, accreditation bodies, testing laboratories and standards developing organizations to discuss and answer questions about the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Draft Guidance published on September 20, 2019.

Background: The ASCA Pilot is intended to support the FDA's public health mission by providing increased confidence in testing from ASCA-accredited testing laboratories, as well as potentially decreasing the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories.

The overarching goals of the ASCA Pilot are to:

  • Enhance confidence in medical device testing
  • Promote consistency and predictability in the premarket review process
  • Encourage effective use of the FDA's resources
  • Enhance regulatory efficiency
  • Support international harmonization

This webinar will provide details about the draft guidance and offer an opportunity for webinar participants to ask questions about the draft guidance.  

Webinar Details:

Registration is not necessary.

Date: Monday, October 28, 2019
Time: 12:00 PM ET – 1:30 PM ET
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

U.S. Callers Dial:

  • 800-779-1636
  • Conference Number: PWXW9431166
  • Passcode: 4106490

International Callers Dial:

  • 1-773-756-0108
  • Conference Number: PWXW9431166
  • Passcode: 4106490

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW9431166&p=4106490&t=c

Following the webinar, a transcript, recording and slides will be available at:

We appreciate your feedback on our webinar program. Following the webinar, we will provide a link to a short survey about your FDA CDRH webinar experience, which should take no more than 5-10 minutes to complete. Your responses are confidential and will be used to help ensure the quality of our webinar program.

Note: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.

Target Audiences: Industry (technology manufacturers (including start-up companies or labs), accreditation bodies, testing laboratories, FDA staff, standards organizations, academic and research institutions, health care facilities, professional societies, foundations and other non-profits.

If you have any questions regarding this draft guidance document, please contact us at ASCA@fda.hhs.gov.

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