Regulatory Counsel

0910-AF87 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Laser Products; Amendment to Performance Standard

FDA is proposing to amend the 2013 proposed rule for the performance standard for laser products, which will amend the performance standard for laser products to achieve closer harmonization between the current standard and the recently amended International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The amendment is intended to update FDA's performance standard to reflect advancements in technology.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No Deregulatory 21 CFR 1002 21 CFR 1010 21 CFR 1040 21 U.S.C. 360hh to 360ss 21 U.S.C. 371 21 U.S.C. 393 No NPRM 06/24/2013 78 FR 37723 NPRM Comment Period End 09/23/2013 NPRM; Withdrawal 08/00/2018 Includes Retrospective Review under E.O. 13563. Yes Businesses Federal State Yes Undetermined Yes No Erica Payne Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3999 301 847-8145 erica.payne@fda.hhs.gov Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517, Silver Spring MD 20993