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| HHS/FDA | RIN: 0910-AF82 | Publication ID: Fall 2011 |
| 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 provide a framework for the reporting of adverse events for combination products. The 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 rule identifies additional 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 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 | |
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Legal Deadline:
None |
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Timetable:
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| 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 | |
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Agency Contact: John Barlow Weiner Associate Director for Policy Department of Health and Human Services Food and Drug Administration Office of Combination Products, W032, Room 5130, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-8930 Fax:301 847-8619 Email: john.weiner@fda.hhs.gov |
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