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HHS/FDA | RIN: 0910-AF82 | Publication ID: Fall 2008 |
Title: Postmarket Safety Reporting for Combination Products | |
Abstract: The proposed rule would clarify the postmarket safety reporting requirements for combination products (combinations of a drug, device, and/or biological product). The proposed rule would provide a framework for the reporting of adverse events for combination products. The proposed rule would clarify that a combination product is subject primarily to the reporting requirements associated with the type of marketing application under which the product is approved or cleared. In addition, the proposed rule identifies unique reporting provisions that must be complied with if applicable. The regulation would ensure the consistency and appropriateness of postmarket safety reporting for combination products while avoiding the need for 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: Proposed 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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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: Undetermined |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Leigh Hayes Regulatory Counsel Department of Health and Human Services Food and Drug Administration Office of Combination Products, Suite 200 (HFG-3), 15800 Crabbs Branch Way, Rockville, MD 20855 Phone:301 427-1934 Fax:301 427-1935 Email: leigh.hayes@fda.hhs.gov |