Regulatory Policy Analyst

0910-AI58 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Contact Lens Devices; Designation of Special Controls for Daily Wear Contact Lenses

FDA is proposing in this rulemaking to designate special controls for daily wear contact lenses in order to address by regulation our current understanding of the risks to health for these devices, which were originally reclassified from class III (premarket approval) into class II (special controls) in 1994. The proposed special controls will reflect the Agency's current guidance and review practice for daily wear contact lenses.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 886.5916 21 CFR 886.5925 sec. 4(b)(3) of the Safe Medical Devices Act of 1990 (SMDA), Pub. L. 101-629, 104 Stat. 4511 (1990) secs. 501, 510, 513, 515, 520, 522, and 701 of the FD&C Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, and 371) No NPRM 12/00/2023 No Businesses None No No No No John Maiers Regulatory Policy Analyst 0910 Food and Drug Administration FDA 301 796-0343 john.maiers@fda.hhs.gov 10903 New Hampshire Avenue, Building 66, Room 5500, Center for Devices and Radiological Health, Silver Spring MD 20993