Another New Pilot Program from CDRH

As we all know the FDA is “committed to making safe and effective medical devices available to patients in an efficient and least burdensome manner.”1  We have already seen this with the CDRH’s “Quik” Review Program Pilot and it continues with the release of a new pilot program that will impact recognized consensus standards. The initiative is called the Accreditation Scheme for Conformity Assessment, or ASCA.

The program’s purpose is to ”streamline the conformity assessment of medical devices when certain FDA recognized standards are used.”1  To help do this the FDA will qualify Accreditation Bodies (ABs) to accredit testing labs (TLs) to meet certain defined criteria based on the current conformity assessment standards. This will ensure that the TL’s results regarding standards conformity are reliable and the CDRH reviewer’s will be able to accept the manufacturers Declaration of Conformity with confidence. This is expected to “increase consistency and predictability in the way FDA determines conformance to standards in product review.”1

The FDA will accredit one or more AB’s based on ISO/IEC 17025 international consensus standards, which specifies the general requirements for the competence of testing and calibration laboratories. Manufacturers will then be able to contract with these AB’s to perform tests per the recognized consensus standards. Device companies may then use the testing results to support their Declaration of Conformity to the standards selected for the ASCA program.

The standards to be selected are yet to be finalized by the FDA (per the ASCA webpage) but it looks like they will focus on the IEC 60601 and ISO 10993 family of standards.

The FDA plans to publish a draft guidance by the end of fiscal year 2019, initiate the program by September 30, 2020 and conclude on October 1, 2022. The Agency states that if the pilot works as planned the program will become permanent and more standards will be added.

 1.The Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognized Standards Pilot Program (ASCA), https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM606720.pdf