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HHS/FDA RIN: 0910-AI58 Publication ID: Spring 2023 
Title: Contact Lens Devices; Designation of Special Controls for Daily Wear Contact Lenses 
Abstract:

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. 

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 886.5916    21 CFR 886.5925   
Legal Authority: 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)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
John Maiers
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 66, Room 5500, Center for Devices and Radiological Health,
Silver Spring, MD 20993
Phone:301 796-0343
Email: john.maiers@fda.hhs.gov