More than 50 medtech testing sites win FDA pilot accreditation

2021-04-14

The FDA announced today that more than 50 laboratory sites were chosen to participate in its program for streamlined regulatory reviews. In total, 53 sites made the FDA’s initial list for participation in its Accreditation Scheme for Conformity Assessment (ASCA) program, which will set out to support more streamlined regulatory reviews of medical device market applicants’ compliance to voluntary consensus standards, according to a news release. All sites selected by the FDA are designated to perform basic safety and essential performance testing to ANSI/AAMI 60601-1 as well as IEC 61010-1 standards for medical devices undergoing 510(k) and other premarket submissions. Also included in the ASCA program is testing to biocompatibility standards such as ISO 10993, although no labs that are currently on the FDA list has been designated to provide such testing at this time. Cook Research Incorporated (CRI), a part of Cook Medical, was one of the 53 sites selected for the ASCA pilot program to increase consistency and predictability with testing that has demonstrated compliance to the technical standards. CRI said in a news release that it was granted designation through the “basic safety” arm of the program. CRI and its 200 employees are located in West Lafayette, Ind. “This accreditation is a landmark both for patients and for Cook,” CRI president Jennifer Kerr said in the release. “Becoming an ASCA-accredited test lab is an acceptance of nonclinical medical device testing because we have demonstrated through this program that we can provide consistently high-quality and scientifically sound testing methodology and outcomes. We can continue our testing knowing we can collectively get devices to patients more efficiently.”

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