Medical Devices; Reports of Corrections and Removals; Companion to Direct Final Rule

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The Food and Drug Administration (FDA) is proposing to amend its regulations governing reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is issued under FDAMA and the act as amended.