Devices

CDRH Posts ASCA Information

CDRH has posted information on its Accreditation Scheme for Conformity Assessment (ASCA), an expansion of the Center’s standards program to include a pilot accreditation initiative to improve the device review process. The post says ASCA allows FDA to work directly with accreditation bodies that will accredit testing laboratories to certain FDA-recognized consensus standards. “Accredited test labs will apply to FDA for recognition demonstrating their ability to perform testing to a specific scope of standards in the ASCA pilot,” it says. The test labs will produce standardized test reports to device sponsors for use in product submissions.

The anticipated outcome of ASCA, CDRH says, will be increased consistency and predictability of the agency’s approach to assessing conformance to standards in product reviews by enhancing FDA’s confidence in testing laboratories’ competence, and thereby in their test methods and results.

The post contains discussion of key questions such as why FDA developed the pilot, why the pilot is being implemented, the expected ASCA benefits, how the pilot program will work, which standards will be included in ASCA, and when the pilot will launch.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome