Abbreviated 510(k) program would shift work from ODE to FDA inspectors, agency staffers say.
This article was originally published in The Gray Sheet
Executive Summary
FDA'S ABBREVIATED 510(k) PLAN WOULD PUT BURDEN ON FIELD INSPECTORS to monitor manufacturers' compliance with standards cited in the premarket submissions, agency staffers say. Under the abbreviated 510(k) plan being developed by the agency, firms would be able to certify conformance of devices to relevant standards rather than submitting data covered by the standard as part of a 510(k) ("The Gray Sheet" June 23, p. 5). Data proving conformance would be kept in-house by manufacturers.