View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AI58 Publication ID: Fall 2020 
Title: ●Contact Lens Devices; Designation of Special Controls for Daily Wear Contact Lenses 

FDA is proposing in this rulemaking to designate the special controls for classifying 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 be derived from the the existing guidance that the Agency uses to review these devices in our premarket notifications (510(k)) program.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Other 
CFR Citation: 21 CFR 886.5916    21 CFR 886.5925   
Legal Authority: sec. 4(b)(3)(D) of the Food and Drug Administration Safety and Innovation Act (SMDA), Pub. L. 101-629, 104 Stat. 4511 (1990)    sec. 520(n) of the Federal Food Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(n), enacted by Pub. L. 109-96, 119 Stat. 2119 (2005)    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
Action Date FR Cite
NPRM  08/00/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  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