Medical devices; device tracking. Final rule.
The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements.
D003219:Confidentiality / Q000331:legislation & jurisprudence*; D003257:Consumer Product Safety; D004868:Equipment Failure; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000145:classification*; D005568:Forms and Records Control / Q000191:economics / Q000331:legislation & jurisprudence*; D006801:Humans; D010355:Patient Identification Systems / Q000331:legislation & jurisprudence; D018907:Privacy / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration