- October 28, 2019
- 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to discuss and answer questions about the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Draft Guidance published on September 20, 2019.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This webinar will provide details about the draft guidance and offer an opportunity for webinar participants to ask questions about the draft guidance.