5/16/2023 0 Comments Pdf elements reviewThe Federal Register notice explains the legal issues and basis for the proposal, and provides information about how interested persons can submit written data, views, or arguments on the proposal. The FDA takes various steps to develop these rules, including publishing a variety of documents in the Federal Register announcing the FDA's interest in formulating, amending or repealing a rule, and offering the public the opportunity to comment on the agency's proposal. Premarket Approval of Medical Devices (21 CFR Part 814)Įach time Congress enacts a law affecting products regulated by the Food and Drug Administration, the FDA develops rules to implement the law.Investigational Device Exemptions (21 CFR Part 812).Applications for FDA Approval of a Biologic License (21 CFR Part 601).New Animal Drug Applications (21 CFR Part 514).New Animal Drugs for Investigational Use (21 CFR Part 511).
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