0910-AG31 201210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Unique Device Identification 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. Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes Private Sector 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 USC 351 21 USC 352 21 USC 360 21 USC 360h 21 USC 360i 21 USC 360j 21 USC 360l 21 USC 371 Statutory Final 05/07/2013 Must be finalized no later than 6 months after end of comment period (November 7, 2012). Deadlines added by section 614 of FDASIA, PL 112-144 Yes 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. 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. 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. 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. 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. NPRM 07/10/2012 77 FR 40735 NPRM Comment Period End 11/07/2012 Final Action 05/00/2013 Yes Businesses None No www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/default.htm www.regulations.gov Yes No John Crowley J. 0910 Food and Drug Administration FDA 301 980-1936 jay.crowley@fda.hhs.gov Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New Hampshire Avenue, Silver Spring MD 20993