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HHS/FDA RIN: 0910-AH71 Publication ID: Spring 2023 
Title: Revision of Product Jurisdiction Regulations 

FDA is amending its regulation on classifying medical products as drugs, devices, biological products, or combination products (products composed of two or more different types of medical products, e.g., a drug and device) and on Center assignment and regulation of combination products, in two respects. First, it would remove a duplicative administrative appeals process for appealing product classification and assignment determinations, streamlining the process for appealing these determinations for product sponsors and FDA staff and making the process more efficient. Second, it would also enhance regulatory clarity and efficiency by removing a provision that might be interpreted inconsistently with new requirements under the 21st Century Cures Act, which addresses when combination products can be marketed under a single application for the complete combination product or under separate applications for each constituent part (e.g., the drug and device) of the combination product.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 3   
Legal Authority: 21 U.S.C. 353(g)    21 U.S.C. 360bbb-2    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  05/15/2018  83 FR 22428   
NPRM Comment Period End  07/16/2018 
Final Rule  10/00/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
John Barlow Weiner
Associate Director for Policy
Department of Health and Human Services
Food and Drug Administration
Office of Combination Products, 10903 New Hampshire Avenue, W032, Room 5130,
Silver Spring, MD 20993
Phone:301 796-8941