FDA launched the ASCA Pilot on September 25, 2020. This pilot would grant ASCA recognition to qualified accreditation bodies to accredit testing laboratories to conduct pre-market testing on medical device companies and their devices.1
The pilot is based on internationally recognized conformity assessment standards and certain FDA-identified specifications. The pilot aims to harmonize the conformance assessment of FDA-recognized consensus standards and test methods to be included in the medical device pre-market reviews.1
This will potentially reduce the burden of reviewing individual pre-market submissions where test reports are submitted from accredited laboratories as well as incorporate internationally recognized assessment standards. This will in turn reduce the review times for pre-market submissions as it would decrease the need for FDA to request additional information about the test methods utilized.1
Testing laboratories can apply for ASCA accreditation in a two-step process where the laboratory is assessed against ISO 17025:2017 requirements and the ASCA pilot-specific requirements.1
FDA has designated more than 50 laboratories to participate in this pilot program. You can find the list here.
Device manufacturers may voluntarily use an ASCA-accredited testing laboratory to conduct testing that will be included in their pre-market submissions. A device manufacturer using an ASCA-accredited testing laboratory under the ASCA Pilot can include a declaration of conformity for the test conducted.1
This effort by the FDA is in line with the practice followed in the EU as it pertains to third-party conformity assessments. I believe that this program has huge potential to reduce the review period of pre-market submissions by the FDA and thus help companies save time and money in the long run.
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1FDA (2021)Accreditation Scheme for Conformity Assessment (ASCA) retrieved on 04/14/2021 from https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/asca-accredited-testing-laboratories?utm_medium=email&utm_source=govdelivery