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HHS/FDA | RIN: 0910-AI58 | Publication ID: Fall 2020 |
Title: ●Contact Lens Devices; Designation of Special Controls for Daily Wear Contact Lenses | |
Abstract:
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. |
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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 |
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Timetable:
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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 Email: john.maiers@fda.hhs.gov |