510(k) "refuse-to-accept" rates vary from 3% to 28% depending on ODE division.
This article was originally published in The Gray Sheet
Executive Summary510(K) "REFUSE-TO-ACCEPT" RATES RANGE FROM 3% TO 28% depending upon the division of the device center's Office of Device Evaluation, according to agency statistics. As of March 31, the Division of Cardiovascular, Respiratory, and Neurological Devices reported the highest refuse rate (28%) while the Division of Clinical Laboratory Devices checked in with the lowest (3%). The figures were compiled in response to House Commerce/Oversight Subcommittee Chairman Joe Barton's (R-Tex.) request for information on FDA's device review program ("The Gray Sheet" March 27, p. 9).
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