The FDA Unveils Draft Guidance on ASCA for Device Conformity Assessment Testing

On Sept. 23, 2019, the U.S. Food and Drug Administration (FDA) Center for Device and Radiological Health’s (CDRH) released draft guidance on its Standards and Conformity Assessment Program’s (S-CAP) new pilot program called the Accreditation Scheme for Conformity Assessment (ASCA). The proposed pilot would create an accredited conformity assessment arrangement between device manufacturers, accreditation bodies and testing laboratories. ASCA’s end goal is to improve efficiencies in the premarket review process through building greater confidence in the Declaration of Conformity through accreditation.(1)

Gail Rodriguez, a senior policy adviser with S-CAP, presented an overview of ASCA at a meeting of the RAPS Utah chapter Nov. 6, 2019, and provided some insights about the pilot program.(2)

How Does It Work

A voluntary program authorized by the Medical Device User Fee Amendments of 2017 (MDUFA IV), ASCA is intended to increase consistency and predictability in the FDA’s approach to assessing conformance by applying ASCA-eligible standards. In simpler terms, it’s hoped that ASCA will reduce the regulatory burden by increasing product reviewers’ trust in medical device testing. In turn, greater assurance in testing and reviews would allow a smaller FDA footprint.

“And that means you’ll need fewer of us and maybe less of your time because, ultimately, it means fewer additional information requests and fewer internal consults,” Rodriguez said.

The program also supports enhanced regulatory efficiency and international harmonization since the program’s testing standards are proven global standards, she said.

Essentially, accreditation bodies could apply to participate in the ASCA pilot and be “recognized” by the FDA as ASCA-accredited accreditation bodies as opposed to being “certified” or “approved” by the FDA. Testing laboratories could then apply for accreditation from recognized accreditation bodies to participate in the program. By course, the FDA would recognize testing laboratories for the ASCA pilot participation and grant them ASCA accreditation. Finally, device manufacturers could select an ASCA-accredited testing laboratory for testing and use those summary test reports in premarket submissions.

In the current framework, accreditation bodies have to be accredited through International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) to demonstrate competence. Accreditation bodies must also conform with ISO/IEC 17025. Under the ASCA pilot, accreditation bodies would use ISO/IEC 17025, including internal audits conducted by testing laboratories, in addition to ASCA program specifications and standards to accredit testing laboratories.

The device standards the FDA is considering using for the pilot program (based on input at a 2018 public workshop) rely mostly on biocompatibility, Rodriguez said. They would preliminarily include Biological Evaluation of Medical Devices (ISO 10993) and Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems and Laboratory Equipment (ANSI/AAMI ES60601-1 and IEC 61010-1).

Who Can Participate

Initially, accreditation bodies eligible to apply for the ASCA pilot program would include U.S.-based accreditation bodies with ILAC accreditation that commit to FDA training and the scope of ILAC signatory status. The same would apply to testing laboratories, except they would not be limited to U.S.-based labs. The FDA estimates that it would take no longer than a couple of months for a testing laboratory to receive ASCA accreditation, Rodriguez said.

Device manufacturers would not need to apply to participate in the ASCA pilot program.(3) And as long as testing is performed by an ASCA-accredited testing laboratory, any type of medical device can be submitted for the pilot’s premarket review. However, manufacturers would still have to address relevant information in the submission, including documenting how testing supports marketing authorization, even if testing is conducted by an ASCA-accredited testing laboratory.

As for the possibility of changes to an accreditation body’s or testing laboratory’s scope of recognition for ASCA, there are three options:

1. Expansion of an accreditation body’s or testing laboratory’s scope to include new standards and/or testing methods.
2. Withdrawal of all or part of an accreditation body’s or testing laboratory’s scope of recognition and no longer a program participant.
3. Suspension of a testing laboratory’s ASCA accreditation. A testing laboratory can continue to participate in the ASCA pilot program, but the FDA has temporarily invalidated the testing laboratory’s ASCA accreditation pending the resolution of identified issues.

The FDA would generally accept ASCA-eligible standards testing result from ASCA-accredited testing laboratories without questioning the validity of test methods or reviewing complete test results. The only exceptions are the following:

• As part of a periodic audit;
• If the summary test report indicates an issue with the testing or device;
• And if the FDA becomes aware of information materially bearing on the safety or effectiveness of the device.

Conclusion

The ASCA pilot program’s draft guidance is currently available for public comment until Dec. 23, 2019. Rodriguez encourages device manufacturers, testing laboratories and accreditation bodies to contribute remarks that will receive consideration in the final draft, which will publish before Sept. 30, 2020. Comments can be submitted to asca@fda.cdrh.gov and more information about the program is available here.

The ASCA pilot program has the potential to facilitate greater efficiencies in the regulatory medical submission process for premarket reviews. Rodriguez said greater collaboration and cooperation between medical device stakeholders and the FDA is at the heart of ASCA.

“We were really excited because (ASCA) relies on the advances of standards and regulatory science,” Rodriguez said. “It’s the biggest program we’ve rolled out in some time.”

Mark Durivage, managing principal consultant at Quality Systems Compliance, is encouraged by the FDA’s approach to the pilot.(5)

“Recent changes in organization, structure, and philosophy at the FDA are a positive sign for the medical device industry,” he said. “This proposed new program is designed to make the regulatory submission process more efficient for the FDA and manufacturers.”

Durivage recommends that testing laboratories interested in applying to the ASCA pilot perform a comprehensive gap analysis to the additional requirements of ISO/IEC 17025 Appendixes A and B prior to seeking accreditation.

References

1. “The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program” U.S. Food and Drug Administration. Sept. 20, 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-conformity-assessment-asca-pilot-program
2. “The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Draft Guidance Webinar” by Stacy Cho. The U.S. Food and Drug Administration. October 28, 2019. https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-accreditation-scheme-conformity-assessment-asca-pilot-program-draft-guidance-10282019
3. Presentation on the Accreditation Scheme for Conformity Assessment (ASCA) pilot program by Gail Rodriguez. RAPS Utah chapter meeting. Nov. 6, 2019.
4. “Frequently Asked Questions (FAQs) About the Accreditation Scheme for Conformity Assessment (ASCA) Pilot” U.S. FDA. https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/frequently-asked-questions-faqs-about-accreditation-scheme-conformity-assessment-asca-pilot
5. “FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Explained” by Mark Durivage. Nov. 13, 2019. https://www.meddeviceonline.com/doc/fda-seeks-public-comment-on-the-accreditation-scheme-for-pilot-program-conformity-assessment-asca-0001?