MECA is pleased to announce that we are accredited under the ASCA Program with the scope of accreditation shown here. If you are interested in submitting your next 510(k) under the ASCA Pilot, please see the links below or contact us for additional information.
What is the ASCA Program?
In August of 2020, the FDA issued (3) guidance documents setting up the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. This pilot program that has been in development for almost 3 years is intended to gather data on a process to streamline part of the 510(k) review process associated with Test Data for FDA Recognized Consensus Standards. The idea behind the pilot is that if the FDA can have confidence in the testing done by 1st party or 3rd party testing laboratories, they can review only a summary of the testing instead of the “full” data. The pilot will additionally open a line of communication between the FDA and the testing facility that should speed up the process where there are questions associated with the testing that was conducted.
The FDA will rely on existing Accreditation Bodies (ABs) and on accreditations of Testing Laboratories (TLs) to the industry recognized standard for laboratory quality systems, ISO 17025:2017. ABs that wish to be recognized to accredit TLs can apply to the FDA for recognition. TLs can apply for Accreditation from a recognized AB, and once that accreditation is granted, to the FDA for accreditation under the Pilot Program.
Once accredited by the FDA, TLs will perform testing and issue a summary test report along with certificates of compliance to a manufacturer. A manufacturer can than submit a 510(k) to the FDA under the ASCA Pilot – in place of a full set of test data, the manufacturer will submit a Declaration of Conformity (DoC), along with the supporting Certificate of Compliance and Summary Test Report from the accredited TL. The idea is that these documents will be enough to support the 510(k) since the TL has been accredited and deemed competent to perform the evaluation & testing against the specific standards that are within their scope of Accreditation under the ASCA Program.