Devices

Device Conformity Assessment Pilot Becoming Permanent

A new 2022 annual report on CDRH’s Accreditation Scheme for Conformity Assessment (ASCA) pilot program says it will transition to a permanent program based on demonstrated review efficiencies. ASCA encourages device sponsors to use FDA-recognized voluntary consensus standards in their submissions because they reduce regulatory burden and promotes quality.

The report summarizes CDRH’s experience in 2022 under the pilot, which received five submissions containing ASCA testing, four with basic safety and essential performance testing and one with biocompatibility testing. The report found that:

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 because the summary test reports were complete and the internal FDA review checklists use a similar format. Reviewers were also able to conduct the conformity assessment elements of the device reviews efficiently.

Additionally, the report noted that in one submission, a device sponsor used ASCA testing for one test and non-ASCA testing for another similar test, and 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.”

CDRH also says that to transition to a permanent program and to implement program improvements recommended in the latest iteration of the device user fee agreement, it will need to update ASCA guidance documents. “The ASCA team intends to prioritize educational programs to encourage participation in ASCA, including at conferences and stand-alone events,” it says. “Timely updates will be published to the ASCA web pages, including changes to the lists of ASCA-recognized accreditation bodies and ASCA-accredited testing laboratories as needed. The ASCA team intends to hold regular meetings with stakeholders to discuss progress on ASCA programmatic details. As appropriate, the ASCA team intends to conduct site visits with accreditation bodies and testing laboratories as part of our obligations under the program specifications.”

Finally, the report says the ASCA team will have discussions with stakeholders on the “development of decision criteria to determine how to appropriately expand the ASCA program. This outreach may entail a public workshop or other means to solicit input on how expansion decisions should be approached.”

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