FDA ASCA Program
FDA ASCA Program
Decrease Time-to-market risk on Premarket Submissions with Eurofins’ FDA ASCA Program
The U.S. Food & Drug Administration (FDA) launched a new pilot program called “Accreditation Scheme for Conformity Assessment”, or “ASCA” in September of 2020. Recently, the FDA announced that the Medical Device User Fee Amendments (MDUFA V) bill passed Congress and was signed by President Biden. This statute directs FDA to convert the Accreditation Scheme for Conformity Assessment (ASCA) from a pilot to a permanent program.
What is the Goal of the FDA ASCA Program?
The FDA ASCA program encourages international harmonization of medical device regulation because it incorporates elements, where appropriate, from a well-established set of international conformity assessment practices and standards. The voluntary ASCA Program does not supplant or alter any other existing statutory or regulatory requirements governing the decision-making process for premarket submissions.
The Program is designed to significantly reduce the amount of supplemental documentation needed to support a declaration of conformity using the ASCA Summary Test Reports.
How Can Medical Device Manufacturers Benefit from Participating in the FDA ASCA Program?
Device manufacturers may voluntarily use an ASCA-accredited testing laboratory to conduct testing to be included in premarket submissions to the FDA. A device manufacturer using an ASCA-accredited testing laboratory to perform testing under the ASCA Program includes a declaration of conformity with any necessary supplemental documentation (for example, an ASCA Summary Test Report) as part of a premarket submission.
Since April 12, 2021, four strategically located Eurofins MET labs in the United States Austin (TX), Baltimore (MD), Cary, (NC), and Union City (CA) have been FDA ASCA-accredited. The accreditation confirms that each of these locations comply with the required qualifications specified under the ASCA scheme, so medical device manufacturers can undergo safety and performance testing.
There are two primary standards covering Basic safety and essential performance that are included in the FDA ASCA Program:
- ANSI/AAMI 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (along with the FDA-recognized collateral and particular standards in the IEC/ISO 60601/80601 family)
- IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements (along with the FDA-recognized standards in the IEC 61010 family)
Please view the ASCA page on the FDA’s website to learn more.