FDA finalizes ASCA pilot guidance as it gears up for launch

The US Food and Drug Administration (FDA) on Thursday issued three final guidances on its Accreditation Scheme for Conformity Assessment (ASCA) pilot program.
 
The program, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV), is meant to increase “consistency, predictability and efficiency” during the premarket review of medical devices by creating a scheme for accrediting third party testing laboratories to eligible consensus standards.
 
Device makers will then be able to use testing performed by accredited labs to support premarket submissions to FDA. (RELATED: FDA details long-awaited standards accreditation pilot in new draft guidance, Regulatory Focus, Regulatory Focus 23 September 2019; FDA discusses standards accreditation pilot ahead of launch, Regulatory Focus 5 February 2020).
 
The suite of guidances were originally packaged as a single document when released in draft form last year and lay out the parameters of the pilot program and explain the roles of the various players involved in the voluntary accreditation scheme. The breakout guidances focus on the two initial categories of device standards that will be included in the pilot, which relate to biological evaluation of medical devices and basic safety and essential performances of medical electrical equipment, medical electrical systems and laboratory medical equipment.
 
According to FDA, the final guidances include clarifications about the pilot program and its implementation and include revised terminology for labs and accreditation bodies participating in the program and more details about how and when the agency will audit participating organizations.
 
The final guidances also clarify that the ASCA summary test report should be completed by the testing laboratory and provided to the device manufacturer. Additionally, the final guidances include new appendices with examples of declarations of conformity for the different standards in the program and new examples of ASCA summary test reports for biocompatibility testing.
 
FDA says it is currently accepting applications from accreditation bodies to participate in the program and says it plans to publish a list of ASCA-recognized accreditation bodies by 25 November 2020. Accreditation bodies interested in making the initial list are instructed to apply by 4 November 2020. FDA says it will also publish a list of accredited testing laboratories but does not give a timeframe for when it expects 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 labs interested in basic safety and essential performance accreditation and the other for labs interested in getting accredited for biocompatibility testing.
 
FDA