FDA finalizes ASCA pilot guidelines as it prepares for launch
Posted on September 24, 2020 | Through
The United States Food and Drug Administration (FDA) on Thursday released three final guidelines on its Conformity Assessment Accreditation (ASCA) pilot program.
The program, resulting from negotiations for the current Changes to fees for the use of medical devices (MDUFA IV), aims to increase “consistency, predictability and efficiency” in the pre-market review of medical devices by creating a system for accreditation of third-party testing laboratories according to standards eligible consensus.
Device manufacturers will then be able to use tests performed by accredited laboratories to support pre-market submissions to the FDA. (RELATED: FDA Details Long-Anticipated Standards Accreditation Pilot Project in New Draft Guidance, Regulatory priority, Regulatory priority September 23, 2019; FDA discusses standards accreditation pilot ahead of launch, Regulatory priority February 5, 2020).
The set of guidelines was originally presented as a single document when it was released as a draft last year and outlined the parameters of the pilot program and explained the roles of the different actors involved in the voluntary accreditation program. . The discussion guides focus on the two initial categories of device standards that will be included in the pilot, which relate to the biological evaluation of medical devices and the basic safety and essential performance of electromedical equipment, electromedical systems and equipment. medical laboratory.
According to the FDA, the final guidelines include clarifications on the pilot program and its implementation and include revised terminology for laboratories and accrediting bodies participating in the program and more details on how and when the agency audit the participating organizations.
The final guidelines also state that the ASCA Summary Test Report must be completed by the testing laboratory and provided to the device manufacturer. In addition, the final guidelines include new appendices with sample statements of compliance for the various program standards and new sample ASCA summary test reports for biocompatibility testing.
The FDA said it is currently accepting applications from accreditation bodies to participate in the program and that it plans to publish a list of accreditation bodies recognized by ASCA by November 25, 2020. Accreditation interested in making the initial list are encouraged to apply by Nov. 4, 2020. The FDA says it will also publish a list of accredited testing laboratories but is not giving a deadline to do so.
The agency has also scheduled two training sessions for accreditation bodies in October and November and two question and answer sessions for testing laboratories, one for laboratories interested in basic safety accreditation and essential performance and one for laboratories interested in accreditation for biocompatibility testing.
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