Postmarket surveillance. Final rule.
The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health.
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D003365:Costs and Cost Analysis; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004867:Equipment Design; D004869:Equipment Safety; D005568:Forms and Records Control; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000191:economics / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration