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HHS/FDA | RIN: 0910-AI32 | Publication ID: Spring 2019 |
Title: ●Classification of Spinal Spheres For Use in Intervertebral Fusion Procedures | |
Abstract:
FDA is proposing to classify spinal spheres for use in intervertebral fusion procedures, an unclassified preamendments device, into class III, subject to premarket approval (PMA). FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device. Based on the recommendations of the Orthopedic and Rehabilitation Devices Panel (Panel held December 12, 2013), FDA is publishing this regulation that, if finalized, will protect and promote the public health by classifying spinal spheres for use in intervertebral fusion procedures.
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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: Regulatory | |
CFR Citation: 21 CFR 888 | |
Legal Authority: 21 U.S.C. 301 et seq., 351, 360 21 U.S.C. 360c 21 U.S.C. 360e 21 U.S.C. 360j 21 U.S.C. 360l 21 U.S.C. 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: Adaeze Teme Regulatory Counsel Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, WO 66, Room 5574, Center for Devices and Radiological Health, Silver Spring, MD 20993 Phone:240 402-0768 Email: adaeze.teme@fda.hhs.gov |