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HHS/FDA RIN: 0910-AI32 Publication ID: Fall 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.

 
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 
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
Timetable:
Action Date FR Cite
NPRM  01/00/2020 
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