Monday, April 12, 2021

ASCA: Initial List of ASCA-Accredited Testing Laboratories

FDA publishes initial list of ASCA-accredited testing laboratories. The ASCA Pilot is a new, voluntary conformity assessment initiative.

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US Food and Drug Administration

ASCA Pilot Update: FDA Publishes Initial List of ASCA-Accredited Testing Laboratories

Today, the U.S. Food and Drug Administration (FDA) published an initial list of ASCA-accredited testing laboratories under the Accreditation Scheme for Conformity Assessment (ASCA) Pilot.

Under the ASCA Pilot, the FDA grants ASCA Accreditation to qualified testing laboratories to perform premarket testing for medical device companies. The ASCA Pilot is intended to increase consistency and predictability in the FDA's approach to assessing conformance with the FDA-recognized consensus standards and test methods included in the ASCA Pilot.

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Questions?

If you have questions about the ASCA Pilot, email ASCA@fda.hhs.gov.


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