Regulatory Counsel

0910-AI32 202104 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Classification of Spinal Spheres For Use in Intervertebral Fusion Procedures

FDA is proposing to classify spinal spheres for use in intervertebral fusion procedures, an unclassified preamendments device, into class III. FDA believes that there is insufficient information to determine that general controls and special controls would provide reasonable assurance of safety and effectiveness for this device. After considering 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.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 888 21 U.S.C. 351 21 U.S.C. 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 No NPRM 06/00/2021 No No None No No No No Laurie Sternberg Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-0425 laurie.sternberg@fda.hhs.gov Suite 200N (HFM-630), 10903 New Hampshire Avenue, Building 66, Room 5517, Silver Spring MD 20993