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HHS/FDA | RIN: 0910-AH71 | Publication ID: Fall 2017 |
Title: ●Revision of Product Jurisdiction Regulations | |
Abstract:
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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
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 |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: Undetermined | |
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 Email: john.weiner@fda.hhs.gov |