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HHS/FDA | RIN: 0910-AF82 | Publication ID: Fall 2013 |
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. | |
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, subchapter B (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 360c to 360f 21 USC 360h to 360j 21 USC 360l 21 USC 360hh to 360ss 21 USC 360aaa to 360bbb 21 USC 371a 21 USC 372 to 374 21 USC 379e 21 USC 381 21 USC 394 42 USC 216 42 USC 262 42 USC 263a 42 USC 264 42 USC 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 | |
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 |