The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive review of test protocols and results for each submission, a process that can be burdensome for both manufacturers and regulatory bodies. Now, the FDA CDRH pilot program Accreditation Scheme for Conformity Assessment (ASCA) offers a streamlined option that standardizes conformity assessments. In addition to fostering quality, this approach may help decrease delays to market to ensure that healthcare providers and patients have continuous access to safe, effective devices.
Launched in September 2020, the ASCA program enhances efficiency for FDA reviews of medical device test methods and results. Through this program, the FDA grants qualified accreditation bodies “ASCA Recognition” to accredit testing laboratories performing premarket testing for medical device companies.
To achieve this accreditation, testing laboratories need to first submit an application that includes the scope of their request. The lab is then audited to ensure compliance to ISO/IEC 17025 and 12 CFR 58 GLP. The audit process includes an evaluation of everything from test protocols, quality systems, and complaint files to personnel qualification and ongoing staff training. After authorization from the accreditation body, final approval is then given by the FDA. To further safeguard quality, participating laboratories are subject to ongoing ASCA-specific audits from the accreditation bodies and the FDA.
These ASCA-accredited laboratories then use methodologies and produce final reports, termed ASCA Summary Test Reports, as outlined by FDA to include the information needed to support a consistent and predictable regulatory review.
The upfront work for ASCA accreditation informs a reviewer that the protocol and reports are up to FDA expectations. As a result, manufacturers choosing to test with an ASCA-accredited laboratory can benefit from a more efficient and timely review process to increase the speed to market for that device.
The full impact of the program will be seen in the coming years. Only a limited number of submissions came from ASCA-accredited labs last year; however, the 2022 ASCA Annual Report trends are promising and may reduce the need for FDA reviewers to scour protocols and final reports for every submission.
For example, in 2022 one medical device manufacturer’s submission included similar testing from both an ASCA-accredited and non-ASCA-accredited lab. For the ASCA test, FDA reviewers found zero deficiencies and were able to conduct their review with increased efficiency and confidence. For the non-ASCA test, however, the report was five times longer and reviewers found four deficiencies, one of them major.1
FDA reviewers encountering deficiencies need to spend added time on their assessment and request additional information from the manufacturer. As a result, any test report with deficiencies will draw out the length of the submission process and necessitate additional work from both FDA reviewers and manufacturers.
Overall, the ASCA program can help medical device manufacturers bring safe, effective medical devices to market without delay. While the process to achieve accreditation is a significant undertaking, the benefits to manufacturers, reviewers, and patients may prove substantial. To date, two laboratories, including Nelson Labs, have achieved ASCA accreditation for biocompatibility with more expected to follow suit in 2023. To view the full list of ASCA-accredited testing laboratories and learn more about the program, visit the FDA’s Standards and Conformity Assessment website.
1. Center for Devices and Radiological Health. Accreditation Scheme for Conformity Assessment (ASCA): Annual Report Calendar Year 2022. FDA. https://www.fda.gov/media/164923/download
This article was written by Audrey Turley, Director Expert Advisory Services, Nelson Labs LLC .