FDA’s first-ever ejection of a third-party reviewer. Excerpted from Pathways’ Picks, August 18, 2021
FDA has kicked an accredited organization out of its third-party 510(k) review program for falsifying records and lying to the agency and a client. The agency announced August 18 that it has officially withdrawn “recognition” of Accelerated Device Approval Services (ADAS) as a third-party reviewer because it was “substantially not in compliance” with federal statutes. ADAS represented a (real person's) name and doctored CV as its head reviewer for 31 510(k) reviews even though that person didn't work for the firm, FDA said in a March 12 letter to the firm. ADAS also falsified interactions with the device center when it communicated to one of its device industry clients, according to FDA. This appears to be the first instance of the agency forcibly withdrawing recognition of an accredited third-party reviewer in the program’s 20-plus years of existence. In the past three to four years, FDA has taken steps to enhance the program, including laying out clearer standards for recognition and withdrawal of third-party review organizations. FDA currently lists nine organizations recognized for the program. As of June 2021, ADAS has taken on 40 510(k) reviews since FY 2021 and has delivered a final decision of “substantially equivalent” on 24 of those and non-substantially equivalent for two.
Excerpted from “Pathways’ Picks August 18: Fees, Ejections, Warning Letters, and More in Medtech Policy,” Market Pathways, August 18, 2021.
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