REMOVAL AND CORRECTION REPORTING BY DISTRIBUTORS IS "NOT NECESSARY,"
This article was originally published in The Gray Sheet
Executive Summary
REMOVAL AND CORRECTION REPORTING BY DISTRIBUTORS IS "NOT NECESSARY," the Health Industry Distributors Association argues in recent comments on FDA's proposed rule governing reports of removals and corrections by manufacturers, distributors and importers. The organization "questions whether the proposed regulation is really necessary or whether it is simply duplicating what is already being achieved by [other] reporting requirements of the Safe Medical Devices Act of 1990."