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HHS/FDA RIN: 0910-AI47 Publication ID: Fall 2020 
Title: Amendments to "Intended Use" Regulations 

In the Federal Register of January 9, 2017 (82 FR 2193), the Food and Drug Administration (FDA) issued a final rule entitled Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’ This final rule creates a new regulation that describes 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).  The final rule also amended FDA’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended uses (21 CFR 201.128 (drugs) and 21 CFR 801.4 (devices)).  FDA subsequently delayed the rule from going into effect until March 19, 2018, and re-opened the docket to invite additional public comment due to concerns from stakeholders with the discrete intended use part of the rule. In March 2018, we delayed the effective date of the intended use amendments until further notice, to allow for further consideration of the substantive issues raised in the comments received.

FDA is seeking to amend the Agency’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended uses (see 21 CFR 201.128 (drugs) and 21 CFR 801.4 (devices)). To provide clarity to regulated industry, FDA is seeking to clarify the definition of intended use.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 201    21 CFR 801   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 352    21 U.S.C. 371(a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  09/23/2020  85 FR 59718   
NPRM Comment Period End  10/23/2020 
Final Rule  01/00/2021 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Kelley Nduom
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6221,
Silver Spring, MD 20993
Phone:301 796-8597