title: Medical devices; establishment registration and device listing for manufacturers and distributors of devices; companion to direct final rule--FDA. Proposed rule.
abstract: The Food and Drug Administration (FDA) is proposing to amend certain regulations governing establishment registration and device listing by domestic distributors. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. These amendments are being made to implement revisions to 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 being issued under FDAMA and the act as amended.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D007221:Industry / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration