Different parts of 21 CFR medical device manufacturers must know about

"21 CFR" stands for "Title 21 of the Code of Federal Regulations," and it encompasses the regulations established by the U.S. Food and Drug Administration (FDA). In the context of medical devices, 21 CFR refers to the specific regulations that govern the designing, manufacturing, distribution, labeling, and usage of medical devices in the United States.

Medical device regulations in 21 CFR cover many topics

  • Quality standards
  • Premarket requirements
  • Postmarket surveillance
  • Labeling
  • Adverse event reporting
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