0910-AG31 201304 Update to 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 Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes No 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 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 06/19/2013 Must be finalized no later than 6 months after end of comment period (December 19, 2012). Deadlines added by section 614 of FDASIA, Public Law 112-144. Yes 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 Yes Businesses None No 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