FDA In Brief: FDA announces pilot program to increase consistency and predictability in premarket reviews of medical devices that use certain FDA-recognized consensus standards
September 20, 2019
“Ensuring patients have access to safe and effective devices is at the core of our mission in the FDA’s Center for Devices and Radiological Health. One way to promote this goal and advance public health is through a strong reliance upon consensus standards, which are developed in cooperation with a variety of stakeholders. These standards, given their contributions to regulatory science and practice, play an increasingly prominent role in ensuring that medical devices are safe and effective. We are pleased to announce we’re expanding our already robust standards program to include a new pilot program called the Accreditation Scheme for Conformity Assessment, or ASCA,” said CAPT. Scott A. Colburn, director of the Standards and Conformity Assessment Program in the FDA’s Center for Devices and Radiological Health. “The draft guidance issued today outlining the new pilot program relies upon significant input from experts and is the result of a collaborative effort by the FDA, medical device industry and the conformity assessment community, which includes accreditation bodies and testing laboratories. The program is another step intended to advance regulatory science in a way that could help ensure safe, effective and high-quality medical devices are available to patients while reducing unnecessary delays.”
Today the U.S. Food and Drug Administration issued a draft guidance outlining the goals and implementation of a new voluntary conformity assessment initiative, the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, designed to promote consistency and predictability in the premarket review process for medical devices, encourage effective use of FDA resources, and enhance regulatory efficiency, while also enhancing confidence in medical device testing.
Under the ASCA Pilot, the FDA would recognize qualified accreditation bodies who would accredit testing laboratories using ASCA program specifications associated with eligible consensus standards included in the Pilot. Consensus standards are frequently used by manufacturers to demonstrate that their devices meet safety and effectiveness expectations. Accredited in-house and independent laboratories, used by manufacturers to conduct premarket testing, may apply to the FDA to participate in the ASCA Pilot. The FDA would recognize and grant ASCA Accreditation to qualified testing laboratories. Medical device manufacturers could then work with these ASCA-accredited testing laboratories to perform testing to the standards included in the ASCA Pilot and use those test results to support premarket submissions to FDA.
Reliance upon ASCA-accredited testing laboratories’ results may increase the consistency, predictability and efficiency of the FDA’s review of premarket submissions by reducing the need for certain aspects of the review process, such as consultations with internal FDA experts regarding testing methods and determinations, review of complete test reports done by laboratories, and additional information requests.
The draft guidance outlines the goals and implementation of the ASCA Pilot program. The FDA is required to establish the ASCA Pilot as part of the 2017 reauthorization of the Medical Device User Fee Act.
# # #
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.