Apr 14, 2021

The US Food and Drug Administration has designated more than 50 laboratory sites to participate in the agency’s Accreditation Scheme for Conformity Assessment (ASCA) program to support more streamlined regulatory reviews of medical device market applicants’ compliance to voluntary consensus standards.

FDA’s initial list of ASCA-accredited laboratories includes 53 sites run by several companies, including UL, CSA Group, Dekra, Eurofins and Intertek.

Support for streamlined medical device safety and performance testing

All sites listed are designated to perform basic safety and essential performance testing to ANSI/AAMI 60601-1 as well as IEC 61010-1 standards for medical devices undergoing FDA 510(k) and other premarket submissions. Testing to biocompatibility standards such as ISO 10993 is also included in the ASCA program, but no laboratories currently on the FDA list of participants have yet been designated to provide such testing.

As previously reported by Emergo by UL, FDA developed the ASCA program to build in more consistency and efficiency during medical device premarket reviews via utilizing third-party laboratories to evaluate manufacturers’ declarations of conformity to safety, performance and biocompatibility standards. Additional details about the ASCA program as well as testing laboratory accreditation may be found in the UL press release.

Additional US FDA medical device regulatory resources:

  • US FDA 510(k) consulting for medical device and IVD companies
  • FDA medical device classification consulting
  • Whitepaper: ISO 10993-1 and biocompatibility for medical devices
  • Whitepaper: Medical device testing requirements for FDA 510(k) submissions