Regulatory Counsel, Center for Devices and Radiological Health

0910-AG30 201610 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 Sunlamp Products; Amendment to the Performance Standard

FDA is updating the performance standard for sunlamp products to improve safety, reflect new scientific information, and work towards harmonization with international standards. For example, incorporating specific elements of the International Electrotechnical Commission's standard by reference will allow the Agency to take advantage of the expertise of the international committees involved in the modernization of the international standard, and, thus, save Agency resources. FDA also plans to include changes to the required warning label.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 1040.20 21 CFR 1002 21 U.S.C. 360ii 21 U.S.C. 360kk 21 U.S.C. 393 21 U.S.C. 371 No NPRM 12/22/2015 80 FR 79505 NPRM Comment Period End 03/21/2016 Final Action 11/00/2016 Undetermined Businesses None Undetermined No No No 0910-AH14 Related to Ian Ostermiller Regulatory Counsel, Center for Devices and Radiological Health 0910 Food and Drug Administration FDA 301 796-5678 ian.ostermiller@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring MD 20993