Oct 6, 2020

As the US Food and Drug Administration formally launches the pilot for its Accreditation Scheme for Conformity Assessment (ASCA) program to streamline testing requirements in medical device premarket reviews, the agency has published three final guidances addressing ASCA program goals, scope and acceptable testing standards.

FDA intends for the ASCA program to utilize accredited third-party testing laboratories to assess premarket applicants’ declarations of conformity to consensus standards for safety, performance and biocompatibility. Utilizing accredited testing labs would help make medical device and IVD premarket reviews more consistent and efficient, according to the regulator.

A recent FDA announcement lays out the three final guidances:

The three final guidances replace a single draft guidance on the ASCA issued by FDA in September 2019. Along with these guidances, the agency has also established timelines and processes for training accreditation bodies and accepting program applications from accreditation bodies and testing labs. Plus, a new process flowchart explains how the ASCA pilot will function.

Accreditation body and testing laboratory applications

Now that the ASCA pilot has launched, FDA will accept applications for accreditation bodies through November 4, 2020; the agency will then publish an initial list of accredited bodies recognized under the ASCA program by November 25th. The list will expand as more accredited bodies apply for participation in the program.

No hard dates are provided for accepting testing laboratory applications. FDA also plans to issue an initial list of ASCA-accredited labs and maintain it throughout the ASCA pilot, however.

ASCA training and Q&A sessions announced

In addition, FDA has set two two-day options for online accreditation body training under the ASCA, in late October and early November. Two Q&A sessions in mid-November will also be provided for testing labs interested in ASCA participation.

Learn more about US FDA medical device regulations at Emergo by UL:

  • US FDA 510(k) consulting for medical device and IVD companies
  • FDA submission support for medical devices and IVDs
  • Whitepaper: Medical device testing requirements for FDA 510(k) submissions

Author

  • Stewart Eisenhart

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