Regulations Regarding “Intended Uses”

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 201 and 801 [Docket No. FDA-2015-N-2002] RIN 0910-AI47 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its medical product “intended use” regulations. This action, if finalized, will amend 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 an approved or cleared medical product is intended for a new use. This action will also repeal and replace the portions of a final rule issued on January 9, 2017, that never became effective. This action is intended to provide direction and ( printed page 59719) clarity to regulated industry and other stakeholders. DATES: Submit either electronic or written comments on the proposed rule by October 23, 2020. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 23, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 23, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) w…