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HHS/FDA RIN: 0910-AG31 Publication ID: 2012 
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 health care 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: Private Sector 
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 
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 (November 7, 2012).  05/07/2013 

Overall Description of Deadline: Deadlines added by section 614 of FDASIA, PL 112-144

Statement of Need: A unique device identification system will help reduce medical errors; will allow FDA, the healthcare community, and industry to more rapidly review and organize adverse event reports; identify problems relating to a particular device (even down to a particular lot or batch, range of serial numbers, or range of manufacturing or expiration dates); and thereby allow for more rapid, effective, corrective actions that focus sharply on the specific devices that are of concern.

Summary of the Legal Basis: Section 519(f) of the FD&C Act (added by sec. 226 of the Food and Drug Administration Amendments Act of 2007) directs the Secretary to promulgate regulations establishing a unique device identification (UDI) system for medical devices, requiring the label of devices to bear a unique identifier that will adequately identify the device through its distribution and use.

Alternatives: FDA considered several alternatives that would allow certain requirements of the proposed rule to vary, such as the required elements of a UDI and the scope of affected devices.

Anticipated Costs and Benefits: FDA estimates that the affected industry would incur one-time and recurring costs, including administrative costs, to change and print labels that include the required elements of a UDI, costs to purchase equipment to print and verify the UDI, and costs to purchase software and integrate and validate the UDI into existing IT systems. FDA anticipates that implementation of a UDI system would help improve the efficiency and accuracy of medical device recalls and medical device adverse event reporting. The proposed rule would also standardize how medical devices are identified and contribute to future potential public health benefits of initiatives aimed at optimizing the use of automated systems in healthcare. Most of these benefits, however, require complementary developments and innovations in the private and public sectors.

Risks: This rule is intended to substantially eliminate existing obstacles to the consistent identification of medical devices used in the United States. UDI will allow FDA to more rapidly and effectively identify and aggregate adverse event reports and is central to improvement in FDA's medical device postmarket surveillance plan. By providing the means to rapidly and accurately identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use.

Timetable:
Action Date FR Cite
NPRM  07/10/2012  77 FR 40735 
NPRM Comment Period End  11/07/2012   
Final Action  05/00/2013   
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

 
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