FDA ASCA Pilot Program

Build confidence in premarket medical device reviews

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:

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 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
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	Americas	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
Specialties	Patient monitoring Imaging Applied energy	Patient monitoring Imaging	Patient monitoring Imaging Applied energy
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