FDA releases three post-pilot ASCA draft guidances

The US Food and Drug Administration (FDA) has issued its first set of draft guidance documents for the full-fledged Accreditation Scheme for Conformity Assessment (ASCA) program following the completion of its pilot phase.

The three draft guidances, which replace the final guidances released by the agency in September 2020, propose improvements to the ASCA program based on feedback from the pilot program as well as demonstrate the agency’s commitments outlined in Medical Device User Fee Amendments 2022 (MDUFA V).

“These draft guidance updates incorporate feedback received through public meetings and webinars, the docket, stakeholder meetings, communications with participating accreditation bodies and testing laboratories, and lessons learned internally from review staff and ASCA staff during the pilot phase,” FDA wrote in a Federal Register notice. “The updates will also allow FDA to appropriately expand ASCA per MDUFA V commitments and expectations.”

The goals of the ASCA program are to improve confidence in medical device testing through FDA-vetted ASCA-accredited testing laboratories, create consistency and predictability through the pre-market review process, make FDA resources more effective and increase regulatory efficiency, and support internal harmonization to International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) and ISO/IEC 17000 series standards.

The program allows qualified accreditation bodies to grant ASCA accreditation to qualified testing laboratories if they adhere to international conformity assessment standards and ASCA program specifications. When a device manufacturer uses a testing laboratory with ASCA accreditation, the laboratory gives the device manufacturer the relevant ASCA program specifications, and the device manufacturer can submit an ASCA summary test report to FDA during the pre-market submission phase that contains a declaration of conformity, which is intended to reduce the need for requesting additional information on a laboratory’s testing methodologies. (RELATED: FDA Details Long-Awaited Standards Accreditation Pilot in New Draft Guidance, Regulatory Focus 23 September 2019; RELATED: FDA finalizes ASCA pilot guidance as it gears up for launch, Regulatory Focus 24 September 2020)

“FDA sought to maximize the use of existing frameworks and arrangements in developing the ASCA Program. This way, accreditation bodies and testing laboratories can participate in the ASCA Program by leveraging existing processes and knowledge, increasing the net benefit of participation,” the agency wrote. “We also believe that, by using and extending existing paradigms, the ASCA Program output will be equally applicable to, and therefore beneficial to, other stakeholders.”

Updates to ASCA program

The agency has sought feedback from stakeholders on the pilot, including holding a virtual workshop in April 2024 on approaches to expand the ASCA program. According to the draft guidance outlining the accreditation scheme for the program, FDA made a commitment in MDUFA V to collaborate with stakeholders in improving and expanding the ASCA program, which may include new consensus standards and test methods.

Changes to the program include the ability for accreditation bodies and testing laboratories to update their scope of their ASCA recognition designation if they develop additional competencies in consensus standards and test methods. Accreditation bodies and testing laboratories may also transfer their ASCA accreditation designation, which requires notifying FDA of the transfer and providing information to the agency so they can determine whether a reassessment of accreditation is needed.

Biocompatibility testing of medical devices

FDA also updated its draft guidance on standards for biocompatibility testing of medical devices within the ASCA program. The draft guidance lists FDA’s consensus standards and test methods in the program, details assessment and accreditation for ASCA testing laboratories, and outlines pre-market submission contents for ASCA-accredited laboratories engaged in biocompatibility testing of medical devices.

The 168-page draft guidance has increased by more than 100 pages from the final guidance document in the pilot program, and now has a substantial appendix containing more detailed information on test method-specific ASCA specifications and summary test reports. Other new additions include a describing the need for competency of an accreditation body’s technical assessors, a section on the scope of ASCA accreditation issued by accreditation bodies, and a section on recommendations for testing laboratories considering participation in the program that includes information on demonstrating competency and developing a test plan for biocompatibility assessments.

FDA also plans to hold a public workshop in November detailing its expansion of the program to include use of chemical testing to support biocompatibility of medical devices.

Basic safety and essential performance of medical equipment

The third draft guidance outlines basic safety and essential performance standards for medical devices the ASCA program, which includes medical electrical equipment, medical electrical systems, and laboratory medical equipment. As with the draft guidance on biocompatibility testing of medical devices, the draft guidance on basic safety and essential performance standards contains consensus standards and test methods, information on assessment and accreditation for testing laboratories, and pre-market submission contents for ASCA-accredited testing laboratory performing basic safety and essential performance testing.

New additions to this draft guidance include a section on the scope of accreditation bodies for testing laboratories, and recommendations for participation in the ASCA program, including the development of a collaborate test plan between device manufacturers and testing laboratories, more information on the use of ASCA summary test reports, and a section noting devices that record, display, or analyze physiological data cannot be evaluated by a testing laboratory.

“In testing these types of devices to FDA-recognized consensus standards, the performance of the device is typically monitored and evaluated for any observations or degradations which impact the intended performance,” they said.

FDA also said it added a new section on subcontracting, and that testing laboratories may subcontract provided the testing is within the scope of ASCA accreditation. “Ultimately, the ASCA-accredited testing laboratory is responsible for the data, testing methodology, and results presented in the test reports provided to the device manufacturer,” the agency wrote.

Draft guidances

FDA releases three post-pilot ASCA draft guidances

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