A2LA Recognized by FDA to Assess Testing Laboratories Under ASCA Pilot Program

A2LA is proud to announce that it has been granted ASCA (Accreditation Scheme for Conformity Assessment) Recognition by the FDA, making it among the first accreditation bodies accepted as a participant in the ASCA Pilot program. The ASCA Pilot is a cooperative program that relies on participation from accreditation bodies, testing laboratories, medical device manufacturers and FDA staff. Accreditation bodies like A2LA that meet the FDA’s requirements for this new program are granted ASCA Recognition, enabling them to assess testing laboratories seeking ASCA accreditation to perform premarket testing for medical device companies. The Pilot is intended to enhance product reviewers' and device manufacturers' confidence in medical device testing, which in turn helps to ensure the widespread accessibility of safe and effective medical devices. 

In addition to supporting the FDA’s public health mission by providing increased confidence in testing results from ASCA-accredited testing laboratories, the ASCA Pilot is expected to reduce the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories. The Pilot relies on international conformity assessment standards and a set of FDA-identified ASCA program specifications to create clear and consistently applied criteria for accreditation, which a limited number of qualified accreditation bodies will be recognized to assess. A2LA is among the largest and most trusted accreditation bodies in the United States and applied for ASCA Recognition at the first opportunity. A2LA’s commitment to the value and broad applicability of third-party accreditation aligns closely with the FDA’s goals in creating this program, and A2LA is eager to serve the medical device testing companies to which this new program applies. 

 “A2LA is recognized as a leader in the global accreditation industry. With that reputation to uphold, we continually seek opportunities to expand the services we are able to provide our customers and to find ways to serve our community.” Said Terrianne Kohr, Accreditation Supervisor at A2LA, and one of the people most closely involved with this new program. “The launch of this new program and cooperation with the FDA is an exciting opportunity for us to realize both of these missions within the medical device field. It is an honor to be among the first accreditation bodies recognized by the FDA to offer assessment services under this Pilot program. We are looking forward to working closely with the FDA and testing laboratories in this endeavor to improve the efficiency of the premarket review process and instill increased confidence in testing results within the industry.” 

For information on how to apply for accreditation to this program, visit our ASCA Pilot program page, or contact us for additional information for both laboratories seeking A2LA accreditation for the first time and those who are already accredited by A2LA and are interested in this new program. Details provided by the FDA on the ASCA Pilot are available here. For any questions about accreditation with A2LA, please call 301-644-3248 or use this link to reach out by email.