Unique Device Identification System

Docket ID: FDA-2011-N-0090
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
RIN: 0910-AG31
Impacts and Effects: International
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
Priority: Economically Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Fall 2013
Agenda Stage of Rulemaking: Completed Action
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: Yes
Energy Effects: No
Included in Regulatory Plan: Yes
Legal Deadline
StatutoryOtherMust be finalized no later than 6 months after end of comment period (December 19, 2012).06/19/2013
ActionDateFR Citation
NPRM07/10/201277 FR 40735
NPRM Comment Period End11/07/2012
Second NPRM11/19/201277 FR 69393
Final Action09/24/201378 FR 58786
Second NPRM Comment Period End12/19/2013
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: FDA-2014-D-1182
Short Title: Unique Device Identification System
Keyword(s): cdrh200816, CDRH, 0910-AG31
Type: Rulemaking
Docket Status: OPEN
Center: CDRH
Docket Item Code: N

Primary Documents

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Comment Period Closed
Dec 19, 2012 11:59 PM ET
Proposed Rule
Posted: 11/19/2012
ID: FDA-2011-N-0090-0222
Comment Period Closed
Nov 07, 2012 11:59 PM ET
Posted: 11/07/2012
ID: FDA-2011-N-0090-0107
Comment Period Closed
Nov 07, 2012 11:59 PM ET
Proposed Rule
Posted: 07/10/2012
ID: FDA-2011-N-0090-0001
Comment Period Closed
Oct 25, 2012 11:59 PM ET
Proposed Rule
Posted: 09/17/2012
ID: FDA-2011-N-0090-0019
Comment Period Closed
Posted: 03/04/2016
ID: FDA-2011-N-0090-0276

Supporting Documents

View All  (9)
Comments Not Accepted
Supporting & Related Material
Posted: 02/01/2013
ID: FDA-2011-N-0090-0273


View All  (262)

Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Current Stage
Agency Contact
John J. Crowley
Senior Advisor for Patient Safety
Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Silver Spring, MD 20993
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.