Oct 6, 2020

The US Food and Drug Administration recently issued final guidance for its highly anticipated Accreditation Scheme for Conformity Assessment (ASCA) pilot, effectively launching the program and setting application deadlines for accredited body and testing laboratory applicants.

FDA has also published a flowchart explaining the steps involved in the ASCA process, and how the program will provide more consistent and streamlined premarket reviews for medical device manufacturers.

ASCA process flowchart

In its flowchart, FDA has identified nine key steps in the ASCA process:

  1. Accreditation bodies apply to FDA to obtain ASCA recognition.
  2. FDA designates ASCA recognition to qualified accreditation bodies based on ASCA program guidance.
  3. Testing laboratories receive accreditation from ASCA-recognized accreditation bodies according to the standard ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories as well as ASCA program guidance.
  4. Testing laboratories then apply to FDA for their own ASCA accreditation.
  5. FDA grants ASCA accreditation to testing laboratories that meet qualifications identified in program guidance.
  6. Medical device manufacturers select ASCA-accredited testing laboratories to conduct safety, performance and/or biocompatibility testing for premarket submissions to FDA reviewers.
  7. ASCA-accredited testing laboratories perform testing, and then provide ASCA summary test reports and related information to manufacturers.
  8. Manufacturers include declarations of conformity as well as ASCA summary test reports in their FDA premarket submissions.
  9. Finally, FDA performs premarket reviews utilizing ASCA pilot program criteria.

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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