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federal_register: 2018-05347

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2018-05347 Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Partial Delay of Effective Date Rule The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to delay the effective date of amendments to the existing medical product "intended use" regulations, contained in the final rule published January 9, 2017, until further notice. This final rule delays the effective date of the amendments to allow further consideration of the substantive issues raised in the comments received regarding the amendments. This action does not delay the effective date of the portions of the January 9, 2017, final rule that describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which remains March 19, 2018. 2018-03-16 2018 3 https://www.federalregister.gov/documents/2018/03/16/2018-05347/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or https://www.govinfo.gov/content/pkg/FR-2018-03-16/pdf/2018-05347.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to delay the effective date of amendments to the existing medical product "intended use" regulations, contained in the final rule published January 9, 2017, until...

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