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HHS/FDA | RIN: 0910-AF82 | Publication ID: Fall 2016 |
Title: Postmarket Safety Reporting for Combination Products | |
Abstract:
The rule would describe the postmarket safety reporting requirements for combination products (combinations of a drug, device, and/or biological product). The rule would clarify that a combination product is subject to the reporting requirements associated with the type of marketing application under which the product is approved, licensed, or cleared, and to certain additional, specified reporting requirements depending on the types of constituent parts (drug, device, or biological product) of which it is comprised. The regulation would ensure the consistency and appropriateness of postmarket safety reporting for combination products while minimizing duplicative reporting requirements. |
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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 4, subpart B (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360bbb 21 U.S.C. 360c to 360f 21 U.S.C. 360h to 360j 21 U.S.C. 360l 21 U.S.C. 360hh to 360ss 21 U.S.C. 371(a) 21 U.S.C. 372 to 374 21 U.S.C. 379e 21 U.S.C. 381 21 U.S.C. 394 42 U.S.C. 216 42 U.S.C. 262 42 U.S.C. 263a 42 U.S.C. 264 42 U.S.C. 271 |
Legal Deadline:
None |
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Timetable:
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Additional Information: Includes Retrospective Review under E.O. 13563 with small business burden reduction. | |
Regulatory Flexibility Analysis Required: No | Government Levels Affected: State |
Small Entities Affected: Businesses | Federalism: Undetermined |
Included in the Regulatory Plan: No | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
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 |