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HHS/FDA | RIN: 0910-AG31 | Publication ID: Spring 2013 |
Title: Unique Device Identification | |
Abstract: FDA is issuing a final rule establishing a unique device identification system for medical devices. A unique device identification system would allow healthcare professionals and others to rapidly and precisely identify a device and obtain important information concerning the device and would reduce medical errors. | |
Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: Yes | Unfunded Mandates: No |
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 21 CFR 830 | |
Legal Authority: 21 USC 351 21 USC 352 21 USC 360 21 USC 360h 21 USC 360i 21 USC 360j 21 USC 360l 21 USC 371 |
Legal Deadline:
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Overall Description of Deadline: Deadlines added by section 614 of FDASIA, Public Law 112-144. |
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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: Yes | |
RIN Information URL: www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/default.htm | Public Comment URL: www.regulations.gov |
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 |