ASCA Becomes a Permanent Program

Effective September 19, 2023, the U.S. Food and Drug Administration’s ASCA Program is converting from a pilot to a permanent program. This transition is authorized by the Medical Device User Fee Amendments of 2022 (MDUFA V).  The ASCA program will continue to be implemented through the final guidance documents.

In December 2020, The U.S. Food and Drug Administration (FDA) recognized IAS under the Accreditation Scheme for Conformity Assessment (ASCA) pilot program to accredit testing laboratories that perform premarket testing for medical device companies. In this program, IAS was granted the ability to accredit testing laboratories using the standard ISO/IEC 17025 and the ASCA program specifications.

The first step in the process is to obtain accreditation from an ASCA-recognized accreditation body (i.e., IAS), which includes an assessment to ISO/IEC 17025 and the ASCA Pilot program specifications. For laboratories already accredited by IAS to ISO/IEC 17025, the process involves a scope expansion by IAS to include the ASCA program specifications. The next step involves the laboratory submittal of an application for ASCA Accreditation to the FDA.

To learn more about IAS Accreditation to the U.S. FDA ASCA Program, click here.

To read the announcement on the U.S. FDA website, click here.