In August of 2020, the FDA issued (3) guidance documents setting up the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. Effective September 19, 2023, the ASCA Program converted from a pilot to a permanent program. The voluntary ASCA Program is an accreditation scheme that capitalizes on the important role that standards play in regulatory. Per the FDA, “the goals of the ASCA program are to:
- Streamline conformity assessment in device submissions
- Enhance the FDA’s confidence in test methods and results
- Decrease the need for additional information related to conformance with a standard
- Promote consistency, predictability, and efficiency in medical device review
- Serve as a least burdensome approach to conformity assessment”
As an ASCA-Accredited Testing Laboratory, MECA serves as a trusted laboratory partner. These evaluations are similar to a traditional Medical Device or Laboratory Equipment Evaluation, but the output of MECA’s review also includes a Summary Test Report and Certificate of Compliance. These documents are intended to be submitted directly to the FDA along with your manufacturer Declaration of Conformity in order to support the 510(k) submission. Per the FDA, “when the device manufacturer includes a declaration of conformity with an ASCA Summary Test Report as part of their premarket submission, the FDA will have confidence in the testing laboratories’ test methods and results and does not intend to request additional information regarding testing methodologies.”
Helpful Links
- FDA ASCA Program (Accreditation Scheme for Conformity Assessment (ASCA) | FDA)
- Information for our Customers (Manufacturers: How to Participate in ASCA | FDA)
- Accredited Labs | our ASCA ID is TL-26 (ASCA-Accredited Testing Laboratories | FDA)
- A2LA ASCA Scope (included on our normal scope) (Touchstone:Accreditation & Assessment Management System – Customer Portal (a2la.org) )
- FDA Consensus Standards (Recognized Consensus Standards: Medical Devices (fda.gov))
- ASCA Pilot Program Guidance (The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program | FDA)
- Basic Safety & Essential Performance Guidance (this is the part of the program MECA is accredited under) (Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program | FDA)