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HHS/FDA | RIN: 0910-AC31 | Publication ID: Spring 2002 |
Title: ●Postmarket Surveillance | |
Abstract: The Food and Drug Administration (FDA) is implementing a final rule for the postmarket surveillance provisions of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health. | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 822 | |
Legal Authority: 21 USC 331 21 USC 352 21 USC 360i 21 USC 360l 21 USC 371 21 USC 374 ... |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
Agency Contact: Joseph M. Sheehan Chief, Regulations Staff Department of Health and Human Services Food and Drug Administration HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone:301 827-2974 Fax:301 594-4765 Email: joseph.sheehan@fda.hhs.gov |