Streamlining Your Medical Device Conformity Assessment with the FDA ASCA Program

FDA approval ensures that new medical devices entering the market are safe, reliable, and suited to their intended purpose, but the stringent approval process is challenging and often lengthy. To support device manufacturers on the path to approval, the FDA developed the Accreditation Scheme for Conformity Assessment (ASCA). Launched as a pilot program in September 2020, ASCA allows manufacturers to test devices to FDA-recognized standards at ASCA-accredited laboratories in preparation for their FDA submission. ASCA-accredited laboratories use uniform test methods approved by the FDA and produce data that directly aligns with the FDA’s internal review checklists. Element currently has five FDA ASCA accredited laboratories throughout the US and has already provided ASCA testing that has been accepted by the FDA.

Does ASCA testing make FDA approval easier?

Ultimately, FDA approval depends on the merits of the device and its ability to meet standardized requirements, but the ASCA program makes it faster and easier for the FDA to accurately evaluate a device’s test results. In early 2023, the FDA released a report examining the ASCA pilot program throughout the year 2022, to determine whether the program achieved its goals of enhancing regulatory efficiency and promoting consistency and predictability in the premarket review process.

Although the number of submissions that included ASCA testing was small, the report provided several indicators of the program’s success. First, the FDA confirmed that test reports issued by ASCA-accredited laboratories included all data and test conditions that the FDA requires and allowed for an efficient conformity assessment process. Second, FDA reviewers asserted greater confidence in the ASCA testing results, compared with non-ASCA results in general.

The report included a specific example where one device sponsor used ASCA-accredited testing in one case and non-ASCA-accredited testing for a separate, similar test requirement. The ASCA test review found zero deficiencies and the length of the report was one-tenth the length of a typical complete test report. The non-ASCA testing found four deficiencies (one major) and the report was approximately five times the length of the report with ASCA testing.

In 2023, based on the successes observed in the pilot program, ASCA was graduated from the pilot stage to a permanent program by passage of the Medical Device User Fee Amendments (MDUFA V) bill.

How can I make use of the ASCA program?

Although many labs offer testing that can be used in FDA submission, only FDA ASCA-accredited laboratories provide testing that matches the FDA’s internal processes and confers the added confidence that the test methods used align with FDA requirements. If you hope to use the ASCA program to your benefit, be certain that the specific laboratory location you use for testing is accredited and that you have requested testing to the ASCA program. Element has multiple ASCA-accredited labs, where testing experts can provide answers to any questions you might have about the program and its benefits.

To learn more about our locations, other accreditations, and the ASCA program, contact us today.