This rule is effective September 1, 2021. This action also withdraws and replaces the portions of a final rule issued on January 9, 2017, that never became effective. This final rule amends FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from Start Printed 84premarket notification is intended for a new use. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its medical product “intended use” regulations. Consultation and Coordination With Indian Tribal Governmentsįood and Drug Administration, HHS. Comments on the Preliminary Economic Analysis of Impacts and Our Response Comments Recommending That FDA Expand the Scope of This Rulemaking Comments on Codified Text and FDA Responses Comments and Responses Regarding Examples Comments and Responses Regarding “Safe Harbors” Comments and Responses Regarding Definitions Comments and Responses Regarding the Fifth Amendment Comments and Responses Regarding the First Amendment Comments and Responses Regarding the Design or Composition of an Article Comments and Responses Regarding Statutory and Regulatory Authority Comments on the Proposed Rule and FDA Responses Introduction and History of This Rulemaking Meaning of Certain Terms in This Preamble Summary of the Major Provisions of the Final Rule This repetition of headings to form internal navigation links Headings within the legal text of Federal Register documents. This table of contents is a navigational tool, processed from the Provide legal notice to the public or judicial notice to the courts. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of
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