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FDA Accreditation Scheme for Conformity Assessment (ASCA) Program

FDA ASCA-accredited testing services from UL Solutions help to increase confidence in premarket medical device testing.
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Build confidence in premarket medical device reviews

The U.S. Food and Drug Administration (FDA) voluntary Accreditation Scheme for Conformity Assessment (ASCA) program is an accreditation scheme that capitalizes on the increasingly prominent role that standards play in regulatory science and practice. ASCA's goals.

  • Streamline conformity assessment in device submissions
  • Enhance the FDA’s confidence in test methods and results
  • Decrease the need for additional information related to conformance with a standard
  • Promote consistency, predictability, and efficiency in medical device review
  • Serve as a least burdensome approach to conformity assessment

Ultimately, ASCA is intended to help the FDA ensure patients have timely and continued access to safer, more effective and high-quality medical devices.

The FDA is implementing ASCA in accordance with:

  • Amendments made to Section 514(d) of the Federal Food, Drug & Cosmetic Act by the Food and Drug Omnibus Reform Act of 2022.
  • The Medical Device User Fee Amendments of 2022 (MDUFA V).

Working with UL Solutions can help:

  • Reduce the number of FDA requests related to testing.
  • Reduce the need for repeat or revised testing.
  • Potentially save time and money spent on retesting with limited documentation requirements.
  • Provide flexibility and consistency in the premarket review process, ranging from a single test to certifications depending on your needs.
  • Assist medical device manufacturers in meeting the FDA's regulatory requirements.
  • Increase your confidence with testing.

Additionally, many of the FDA-recognized consensus standards and test methods included in the ASCA program 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 program:

STANDARD DESCRIPTION
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

Region America Europe Asia
Locations Brea, California Fremont, California Mounds View, Minnesota Northbrook, Illinois Melville, New York Research Triangle Park, North Carolina Neu Isenburg, Germany Warsaw, Poland Milan, Italy Ise-Shi Mie-Ken, Japan Guangzhou, China Suzhou, China Taipei, Taiwan
Collaterals X-ray Alarms Home use Emergency medical X-ray Alarms Home use Emergency medical X-ray Alarms Home use
EMC Fremont, California Northbrook, Illinois Research Triangle Park, North Carolina Milan, Italy Guangzhou, China Taipei, Taiwan

Introduction to the U.S. FDA’s ASCA program

Learn about the Accreditation Scheme for Conformity Assessment program and its effect on medical device testing.

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Downloads

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