Apr 9, 2024 · As required by law, the Food and Drug Administration publishes regulations in the Federal Register, the federal government's official publication for notifying the public of many …

The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR. Learn more about the eCFR, its status, …

Dec 24, 2024 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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If you believe that someone at FDA did not follow the procedures in this section or that someone at FDA treated a guidance document as a binding requirement, you should contact that …

Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115 (b)). These documents usually discuss more specific products or issues that relate to the...

Mar 29, 2024 · FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate …

FDA subject matter experts present overview of FDA’s regulatory review and research activities, product quality and safety responsibilities.

In order to be legally marketed in the United States, many medical devices must be reviewed by the Food and Drug Administration (FDA), the agency responsible for protecting the public …

EPA and FDA are considering how best to update their respective oversight responsibilities for specific products in an efficient and transparent manner and in alignment with each agency’s …