0910-AF86 200904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Device Reporting; Electronic Submission Requirements Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 803 21 USC 352 21 USC 360 21 USC 360i 21 USC 360j 21 USC 371 21 USC 374 Yes NPRM 08/00/2009 Undetermined Undetermined Undetermined No No Yes Madhusoodana Nambiar 0910 Food and Drug Administration FDA 301 796-5837 301 847-8145 madhusoodana.nambiar@fda.hhs.gov Center for Devices and Radiological Health, WO 66, Room 5518, 10903 New Hampshire Avenue, Silver Spring MD 20993