0910-AH71 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Revision of Product Jurisdiction Regulations

FDA is proposing to amend 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 address 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.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No Deregulatory 21 CFR 3 21 U.S.C. 353(g) 21 U.S.C. 360bbb-2 21 U.S.C. 371 No NPRM 05/00/2018 Undetermined Undetermined Undetermined No No John Weiner Barlow Associate Director for Policy 0910 Food and Drug Administration FDA 301 796-8941 john.weiner@fda.hhs.gov Office of Combination Products, 10903 New Hampshire Avenue, W032, Room 5130, Silver Spring MD 20993