View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
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:
Action Source Description Date
Final  Statutory  Must be finalized no later than 6 months after end of comment period (December 19, 2012).  06/19/2013 

Overall Description of Deadline: Deadlines added by section 614 of FDASIA, Public Law 112-144.

Timetable:
Action Date FR Cite
NPRM  07/10/2012  77 FR 40735   
NPRM Comment Period End  11/07/2012 
Second NPRM  11/19/2012  77 FR 69393   
Second NPRM Comment Period End  12/19/2013 
Final Action  07/00/2013 
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