October 12, 2023
Adherence to the voluntary program can help medical device makers improve their regulatory submissions and potentially expedite the review process
Effective Sept. 19, the Food and Drug Administration has converted its Accreditation Scheme for Conformity Assessment (ASCA) Program from a pilot to a permanent program. The ASCA Program will be implemented through the final guidance document.
Goals of a permanent ASCA Program
Transitioning from a pilot to permanent program is a key step for ASCA. The intent is to help increase the efficiency of the regulatory review process by leveraging lab quality systems and procedures to increase confidence in and expedite the review of preclinical data.
While the program is a voluntary accreditation scheme, it aims to take advantage of the important role standards play in regulatory practice and "help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices."
Specific goals of the program include:
- Streamlining the conformity assessment of submissions
- Enhancing confidence in test methods and results
- Reducing the need for additional information while assuring conformance to a standard
- Supporting consistent, predictable, and efficient review
Related information on participation and accreditation
The following information on the ASCA Program is also available:
- ASCA Recognized Accreditation Bodies
- Accreditation Bodies: How to Participate in ASCA
- ASCA-Accredited Testing Laboratories
- Testing Laboratories: How to Participate in ASCA
- Manufacturers: How to Participate in ASCA
- Recognized Consensus Standards: Medical Devices
Recommendations for medical device sponsors
ASCA participation is focused on third-party and manufacturer-based labs that are accredited for methods recognized by the program. Standards development organizations and their stakeholders, including manufacturer participants, should be aware of the program, as it relies on consensus standards. Device manufacturers should continue to monitor the evolution of the ASCA Program, since both the recognized standards and the associated labs may change over time.
What Can We Help You Solve?
Exponent's biomedical science and engineering experts have decades of experience assessing new medical devices, performing expert biomedical laboratory services, and providing sophisticated regulatory support. We have been closely following the ASCA pilot to be ready to help interpret standards and FDA guidance and ensure our clients have access to the program.