CSA Group Laboratories across North America and Asia awarded accreditation as part of ASCA pilot geared at increasing consistency and predictability in the FDA’s medical device clearance process and assessments

CSA Group has been selected as an accredited testing laboratory under the U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, permitting it to conduct medical device testing in accordance with ISO/IEC 17025 and the ASCA program specifications. This accreditation authorizes seven CSA Group testing laboratories across North America and Asia to test medical devices destined for the U.S. market.

Relying upon international conformity assessment standards and a set of FDA-identified ASCA program specifications, this pilot program is intended to increase consistency and predictability in the FDA’s approach to assessing conformance with FDA-recognized consensus standards and test methods in medical device premarket reviews. Choosing an ASCA accredited test lab, like CSA Group, to test for conformity to FDA-recognized standards will allow product reviewers and manufacturers to address certain questions of safety and effectiveness thoroughly and efficiently, potentially decreasing the burden of individual premarket submissions.

To receive accreditation, CSA Group testing labs were assessed by an ASCA-recognized accreditation body to confirm adherence to international standards for testing laboratories, as well as pilot-specific requirements. The pilot-specific requirements included a variety of biocompatibility and basic safety and essential performance standards determined by the FDA.

CSA Group offers ASCA-accredited laboratory testing of medical devices in seven locations: Toronto, Ontario; Montreal, Quebec; Richmond, British Columbia; Irvine, California; Shanghai, China; Seoul, South Korea and Tokyo, Japan.

CSA Group is a global leader in testing and certification of medical and laboratory products. CSA Group supports manufacturers of electro-medical equipment/systems, and laboratory equipment with testing and certification services to help them get their products to patients and healthcare professionals all over the world.

Visit https://www.csagroup.org/asca/ or contact us at:

Europe Head Office:  info.europe@csagroup.org

Corporate Head Office: client.services@csagroup.org.