U.S. FDA recognizes the International Accreditation Service (IAS) to accredit testing laboratories to test medical devices under ASCA program

The U.S. Food and Drug Administration (FDA) has recognized the International Accreditation Service (IAS) under the Accreditation Scheme for Conformity Assessment (ASCA) pilot program to accredit testing laboratories that perform premarket testing for medical device companies.

“IAS is pleased to be a part of this FDA ASCA pilot program that may lead to improvements in medical devices,” said Raj Nathan, IAS President. In this program, IAS will accredit testing laboratories using the standard ISO/IEC 17025 and the ASCA program specifications.

Relying upon international conformity assessment standards and a set of FDA-identified ASCA program specifications, the pilot is intended to increase consistency and predictability in the FDA’s approach to assessing conformance with FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA Pilot in medical device premarket reviews. Ultimately, the ASCA Pilot is intended to help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices.

Testing laboratories interested in getting more information or applying for accreditation may click to enter the IAS FDA ASCA Accreditation Program.