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HHS/FDA RIN: 0910-AI47 Publication ID: Spring 2021 
Title: Regulations Regarding "Intended Uses" 

FDA is finalizing amendments to its "intended use” regulations for medical products ( 201.128 and 804.1).  This action amends FDA’s regulations describing the types of evidence that are 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.   

The Agency issued a proposed rule in 2015 and a final rule in 2017 revising the language of its medical product intended use regulations, with the intent to conform them to the Agency’s current practice in applying the regulations. Comments raised legal concerns with the January 2017, final rule. Although the 2015 proposed rule had received favorable reactions, commenters on the January 2017, final rule criticized changes that were made in the process of finalizing the rule. After receiving a petition that requested the Agency reconsider these amendments, FDA delayed the effective date of the 2017 final rule and reopened the docket to invite public comment. On March 18, 2018, FDA delayed the effective date of the intended use amendments until further notice to allow further consideration of the substantive issues raised in the comments received. 

After considering these issues, FDA issued a proposed rule in September 2020, to repeal the portions of the January 2017, final rule that never became effective, and proposed a new rule to clarify the types of evidence that are relevant in determining a product’s intended uses, thereby supporting FDA’s ability to regulate medical products, including drugs and devices.  This action finalizes the amendments to the intended use regulations. 

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 
CFR Citation: 21 CFR 201    21 CFR 801   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 343(r)    21 U.S.C. 353(g)    21 U.S.C. 371(a)    21 U.S.C. 360ee(b)(3)    42 U.S.C. 216    42 U.S.C. 241    42 U.S.C. 262(i)    42 U.S.C. 262(j)    42 U.S.C. 264   
Legal Deadline:  None
Action Date FR Cite
NPRM  09/23/2020  85 FR 59718   
NPRM Comment Period End  10/23/2020 
Final Rule  07/00/2021 
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
Senior 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