Postmarket surveillance. Final rule.
Copyright policy )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.
Equipment Safety, Consumer Product Safety, United States Food and Drug Administration, Costs and Cost Analysis, Device Approval, Product Surveillance, Postmarketing, Humans, Equipment Design, Forms and Records Control, United States
Equipment Safety, Consumer Product Safety, United States Food and Drug Administration, Costs and Cost Analysis, Device Approval, Product Surveillance, Postmarketing, Humans, Equipment Design, Forms and Records Control, United States
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