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HHS/FDA | RIN: 0910-AG31 | Publication ID: Fall 2009 |
Title: ●Unique Device Identification | |
Abstract: The Food and Drug Administration Amendments Act of 2007, amended the Food, Drug, and Cosmetic Act by adding section 519(f), 21 USC 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: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
Major: Undetermined | Unfunded Mandates: Undetermined |
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: Not Yet Determined |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: Undetermined | |
Included in the Regulatory Plan: No | |
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: No | |
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 |