Agency publishes details for conformity assessment

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published additional information on its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment, or ASCA. The ASCA Pilot Program aims to enhance the predictability of the medical device review process by reducing premarket questions in areas where current conformity activities result in inconsistent testing practices, conformance declarations, and regulatory review.

The CDRH has worked with industry to develop consensus standards and improve post-market safety and performance evaluation with better understanding of device testing and analysis. Participants agreed that the approach used has the potential to significantly promote the use of consensus standards, reduce burden on manufacturers, and enhance conformity assessment processes.  

How it will work

The agency envisions that under the program, the FDA will define a conformity assessment scheme describing the interactions between and specifications for accreditation bodies and testing labs. The FDA will select one or more accreditation bodies that meet FDA-specified program requirements to accredit testing laboratories to assess conformance with certain standards.

The ASCA program will specify participation and performance requirements for accreditation bodies and testing labs involved in medical device conformance, as well as clearly establish conditions for suspension from the program.

To promote transparency, the FDA intends to publicly post information on the agency’s web site about ASCA testing labs, including the FDA-recognized consensus standards for which they are accredited.

Manufacturers will be able to contract with the ASCA recognized testing labs to perform testing and provide test reports and summaries. Manufacturers can then use this information to support a Declaration of Conformity (per 2 ISO/IEC 17050 ‘Conformity assessment – Supplier’s declaration of conformity’) to standards in the ASCA pilot.

Which standards will likely be included?

While the FDA is still determining the standards to be included in the program, its consultations with stakeholders have identified two areas that are likely to be covered: biological evaluation of medical devices, and basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory equipment.

The ASCA Pilot Program is scheduled to launch by September 30, 2020, but the agency says it is working to launch as soon as possible before that date.

Need help navigating the FDA submission process? Kapstone Medical has the experience and expertise across the full range of medical device manufacturing to get your submission accepted.

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Sources: FDA website, “Accreditation Scheme for Conformity Assessment.”


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