FDA Opens Comments on Proposed Laboratory Accreditation Program

The FDA took the first step on the long road of launching a proposed new laboratory accreditation program this month – the Accreditation Scheme for Conformity Assessment (ASCA).

In early April 2017, the US House and Senate committees released a bill to reauthorize the Medical Device User Fee Act (MDUFA IV). As part of the reauthorization negotiations, the US FDA and representatives from the medical device industry agreed to establish an Accreditation Scheme for Conformity Assessment (ASCA).

Under this scheme, the Agency intends to establish a pilot program in which testing laboratories (such as iuvo BioScience) may seek accreditation to evaluate medical devices in accordance with specific FDA-recognized consensus standards. Sponsors of medical device submissions who choose to conduct their testing at these accredited labs will benefit from this initiative as the Agency intends to rely on the results of testing from these accredited labs without seeking additional consensus standard conformance related information.

The proposed timing for the ASCA calls for the FDA to publish a draft guidance document outlining the goals and implementation strategy for this pilot program no later than September 30, 2019. In addition, it also calls for the Agency to initiate the pilot program no later than September 30, 2020 and to draft a final guidance document no later than September 20, 2021. Unless reauthorized as part of MDUFA V, this pilot program will sunset on October 1, 2022.

In preparation for this initiative the FDA published a Request for Comments in the Federal Register on May 16, 2017 (FR Vol. 82, No. 93). Among other things, the Agency is seeking comments addressing what impact/efficiencies stakeholders would like to see, what FDA recognized consensus standards should be included, and whether laboratories would consider participating in the ASCA pilot program and to what extent.

In light of the fact that the ASCA pilot project could benefit our medical device customers, iuvo BioScience is particularly interested in participating in the program and will continue to follow its progress.

For additional information on MDUFA IV please Click Here.  

For additional information on the FDA’s Request for Comments please Click Here.