
Medical Testing Services Overview Brochure (English)
FDA ASCA-accredited testing services from UL Solutions help to increase confidence in premarket medical device testing.
The U.S. Food and Drug Administration (FDA) voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot program is designed to improve the premarket review process. It was created to increase FDA product reviewers’ and device manufacturers’ confidence in medical device testing when performed by an ASCA-accredited laboratory and should help reduce the need for additional testing or information during the premarket review process.
As of April 2021, UL Solutions is an FDA ASCA-accredited testing laboratory. Our healthcare experts have a deep understanding of the industry and offer comprehensive testing and certification services throughout the entire production life cycle. With testing services conducted in one of nine laboratories across the U.S., Europe and Asia, we can help you take advantage of this program and build confidence in the process. When using UL Solutions to perform testing, you can reference this testing in your declaration of conformity (DOC) and provide all necessary supplemental information.
Working with UL Solutions can help:
Additionally, many of the FDA-recognized consensus standards and test methods included in the ASCA Pilot are based on international consensus standards. As a result, UL Solutions’ FDA ASCA scope of accreditation covers the majority of the global standards and helps support international harmonization.
Here are the two primary standards covering basic safety and essential performance that are included in the FDA ASCA Pilot:
STANDARD | DESCRIPTION |
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ANSI/AAMI 60601-1 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (Including the FDA-recognized list of collateral and particular standards of the IEC/ISO 60601/80601 series of medical standards) |
IEC 61010-1 | Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements (along with the FDA-recognized particular standards of the IEC 61010 series of laboratory standards family) |
Our FDA ASCA laboratory offerings
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View our accreditation scope for the ASCA Pilot program.
Learn about the new Accreditation Scheme for Conformity Assessment Pilot program and its effect on medical device testing.