Is ASCA worth it? FDA’s Accreditation Scheme for Conformity Assessment

June 28, 2023By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Philip Won

The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.  Use of voluntary consensus standards can reduce regulatory burden, streamline conformity assessment, harmonize requirements globally, and enhance the quality and safety of a device. As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted.

ASCA was authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In accordance with amendments made to section 514 by the FDA Reauthorization Act of 2017 (FDARA), and as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA was directed to issue guidance regarding the goals and implementation of the ASCA Pilot. The MDUFA V reauthorization converts the ASCA Pilot to a permanent program.

If a device manufacturer chooses to use an ASCA-accredited testing laboratory to conduct testing for premarket submissions to the FDA, the device manufacturer includes an ASCA declaration of conformity, an ASCA Summary Test Report and a cover letter that indicates that the submission contains ASCA testing as part of their premarket submission. For testing conducted under ASCA, the FDA will have confidence in the testing laboratories’ test methods and results and does not intend to request additional information regarding testing methodologies.

ASCA includes FDA-recognized consensus standards and related test methods across two scopes: biocompatibility and basic safety and essential performance. FDA selected these categories of standards because they are used for the majority of devices and are frequently associated with FDA requests for additional information.  For the nine most common biocompatibility test methods, there are nine ASCA Summary Test Report templates that are used to document results.  There is one ASCA Summary Test Report template available to document results for basic safety and essential performance.

2022 Device Submissions with ASCA Testing

According to the ASCA 2022 Annual Report, the “FDA received five submissions that contain ASCA testing: four with basic safety and essential performance testing and one with biocompatibility testing. The following conclusions were drawn from these submissions:

  • The ASCA Summary Test Reports used the format provided in the ASCA standards-specific guidance documents and the declarations of conformity and Summary Test Reports included all critical data and testing conditions.
  • FDA reviewers had greater confidence in the ASCA testing results, and because the ASCA Summary Test Reports were complete and because the internal FDA review checklists use a similar format, reviewers were able to conduct the conformity assessment elements of the device reviews efficiently.
  • In one submission, a device sponsor used ASCA testing for one test (60601-1) and non-ASCA testing for another, similar test (60601-1-2). The results showed that the ASCA test review found zero deficiencies and the length of the report was one-tenth the length of a typical complete test report. The non-ASCA testing found four deficiencies (one major) and the report was approximately five times the length of the report with ASCA testing.”

Using an ASCA-accredited testing laboratory to produces test results using the ASCA template may reduce the need for a lead reviewer to request consultations on a submission and reduce the size of the report submitted, thereby saving time on during the premarket review.  FDA recently shared some statistics on the impact of ASCA during the FDA Small Business Regulatory Education for Industry (REdI) Annual Conference held on June 5-9, 2023.  Using an infusion pump as an example, the review time for six biocompatibility tests and electrical safety/EMC testing would go from approximately 21 hours to 3 hours, with no need for an additional consultation.

As industry is always looking for ways to improve speed to market and create more predictable timelines for regulatory submission, ASCA may provide that advantage, at least when it comes to biocompatibility and basic safety and essential performance. We look forward to reviewing the 2023 Annual Report when published to see if there are more statistics on submissions using ASCA.

Categories: Medical Devices