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FDA Grants First ASCA Accreditations to Labs to Perform Premarket Testing

NEW YORK – The US Food and Drug Administration on Monday published its initial lists of laboratories of accredited laboratories under the Accreditation Scheme for Conformity Assessment Pilot. 

The accredited labs are qualified to perform premarket testing for medical device companies. FDA's pilot is intended to increase consistency and predictability in the agency's approach to determining conformity with consensus standards and test methods, the agency said in a statement.

Specifically, it is supposed to enhance product reviewers' and device manufacturers' confidence in medical device testing, hopefully decreasing the need for the agency to request additional information on testing methodologies when a premarket submission has been included in the pilot.

The initial list includes laboratories across the US and the world, including three Eurofins Electrical and Electronic Testing labs in the US, Certification Entity for Renewable Energies in Spain, and CSA Group labs in South Korea, Japan, and Canada. The accreditation bodies that have received ASCA recognition are International Accreditation Service, A2LA, ANSI National Accreditation Board, Perry Johnson Laboratory Accreditation and the National Voluntary Laboratory Accreditation Program.  

The voluntary pilot program began in September with the goal of potentially decreasing the burden of individual premarket submissions in cases where manufacturers rely on testing completed by ASCA-accredited testing labs. The program also incorporates existing international conformity assessment standards and practices where practical, the FDA said.

Accreditation bodies must apply to the FDA for ASCA Recognition. Testing labs are assessed by an ASCA-recognized accreditation body to see if they adhere to international standards for testing and calibration laboratories, as well as pilot-specific requirements. If they do, they can apply for accreditation and, once granted, a device manufacturer can use the lab for testing for the premarket submission. 

The pilot-specific requirements include a variety of biocompatibility and basic safety and essential performance standards determined by the FDA.