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HHS/FDA | RIN: 0910-AG31 | Publication ID: Spring 2011 |
Title: Unique Device Identification | |
Abstract: The Food and Drug Administration Amendments Act of 2007 (FDAAA), amended the Federal Food, Drug, and Cosmetic Act by adding section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to promulgate regulations establishing a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDA specifies an alternative placement or provides for exceptions. The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number. | |
Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Yes | Unfunded Mandates: Undetermined |
CFR Citation: 21 CFR 16 21 CFR 801 21 CFR 803 21 CFR 806 21 CFR 810 21 CFR 814 21 CFR 820 21 CFR 821 21 CFR 822 | |
Legal Authority: Not Yet Determined |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Undetermined |
Small Entities Affected: Businesses | Federalism: Undetermined |
Included in the Regulatory Plan: Yes | |
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: Yes | |
Agency Contact: John J. Crowley Senior Advisor for Patient Safety Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 980-1936 Email: jay.crowley@fda.hhs.gov |