Unique Device Identification System

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Docket ID : FDA-2011-N-0090
Agency : Food and Drug Administration (FDA)
Parent Agency : Department of Health and Human Services (HHS)
Summary :
FDA is issuing a final rule establishing a unique device identification system for medical devices. A unique device identification system would allow health care professionals and others to rapidly and precisely identify a device and obtain important information concerning the device and would reduce medical errors.
RIN : 0910-AG31
Impacts and Effects : None
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
Priority : Economically Significant
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UA and Regulatory Plan Information open glossary dialog  
Publication Period: Fall 2012
Agenda Stage of Rulemaking: Final Rule
Major Rule: Yes
Legal Authorities: 21 USC 351, 21 USC 352, 21 USC 360, 21 USC 360h, 21 USC 360i, 21 USC 360j, 21 USC 360l, 21 USC 371
Government Levels Affected: No
Federalism Implications: No
Unfunded Mandates: Private Sector
Requires Regulatory Flexibility Analysis: Business
Small Entities Affected: No
International Impacts: No
Energy Effects: No
Included in Regulatory Plan: Yes
Legal Deadline
Action Source Description Date
Other Statutory Must be finalized no later than 6 months after end of comment period (November 7, 2012). 05/07/2013
Timetable
Action Date FR Citation
NPRM 07/10/2012 77 FR 40735
NPRM Comment Period End 11/07/2012
Final Action 05/00/2013
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Docket Item Code: N
Type: Rulemaking
Center: CDER
Short Title: Unique Device Identification System
Keyword(s): cdrh200816, CDRH, 0910-AG31
Docket Status: OPEN
 
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288
Comments Received *
* The total reflects comments received from Regulations.gov and other means as of 11:59 PM yesterday. All comments received may not be posted at this time including bulk submissions; therefore, the total comments received and posted may differ.
Regulatory Timeline
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Proposed Rule
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Final Rule
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