By Lisa M. Baumhardt, Principal Medical Device Regulatory Expert —
In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV). As we previously blogged, under the FDA Reauthorization Act of 2017 (FDARA), FDA committed to establish an ASCA Program using FDA-recognized consensus standards. The ASCA pilot program concluded in 2023 after seven (7) years based on data demonstrating the pilot’s objectives were met or surpassed.
Under the ASCA program, FDA grants ASCA Recognition to qualified accreditation bodies to accredit testing laboratories, thereby granting the laboratories ASCA Accreditation. The ASCA accredited testing laboratories perform testing for medical device companies to include in premarket submissions. A Sponsor can choose to use an ASCA accredited laboratory for basic safety and essential performance and/or biocompatibility testing.
ASCA is designed to
- Enhance confidence in medical device testing;
- Promote consistency and predictability in the premarket review process;
- Encourage effective use of FDA resources;
- Enhance regulatory efficiency; and
- Support international harmonization.
When using ASCA, Summary Test Reports are included in a premarket submission using the format provided in the ASCA standards-specific guidance documents. Summary Test Reports and Declarations of Conformity include all critical data and testing conditions so that full test reports are not needed, making FDA’s review of the data during the submission more efficient. FDA has stated by including ASCA Summary Test Reports in submissions, they “will have confidence in the testing laboratories’ test methods and results.”
According to the ASCA 2024 Annual Report, the FDA received seventy-one (71) device submissions that contained ASCA accredited laboratory Summary Test Reports, a significant increase over the five (5) submissions received in 2022. While the number of submissions containing ASCA Summary Test Reports is growing, the numbers still appear to be low given the number of submissions FDA receives for devices that are required to include basic safety and essential performance or biocompatibility documentation.
The majority of device submissions that included ASCA Summary Test Reports were for basic safety and essential performance, with only 25% for biocompatibility. The good news is that out of the seventy-one (71) submissions noted in the 2024 Annual Report, only one (1) submission had deficiencies and only one (1) submission required FDA to request a full test report. The fact that the majority of submissions that included ASCA Summary Test Reports successfully met biocompatibility and basic safety and essential performance requirements—which are areas Sponsors typically receive Additional Information requests—suggests the training provided by ASCA to both laboratories and Sponsors is paying off. Prior to November 2023, FDA identified administrative and technical deficiencies in approximately 37% of submissions with ASCA Summary Test Reports during the pilot phase of the program.
As of December 2024, there are now 107 testing laboratories under ASCA Accreditation (102 for basic safety and essential performance and five (5) for biocompatibility), which gives Sponsors seeking to avail themselves of the ASCA program many options. It should be noted, however, six (6) laboratories did request to withdraw from the program, for reasons not disclosed in FDA’s Annual Report.
As FDA’s concerns related to unreliable device biocompatibility testing data continue (see our blog post here), Sponsors may want to consider evaluating if an ASCA accredited testing laboratory could be a means to ensure the quality of their biocompatibility test data. In addition, Sponsors seeking to improve their device submission predictability, may want to consider an ASCA accredited testing laboratory for basic safety and essential performance and biocompatibility testing.
