This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office] .
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
United States Code U.S. Code: Title 21 - FOOD AND DRUGS
Title 21 published on 20-Sep-2017 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 888 after this date.
2017-01-09; vol. 82 # 5 - Monday, January 9, 2017 82 FR - Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration 21 CFR Part 888 Summary
2016-12-30; vol. 81 # 251 - Friday, December 30, 2016 81 FR 96366 - Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective on December 30, 2016. See further discussion in section V, “Implementation Strategy.” 21 CFR Part 888 Summary The Food and Drug Administration (FDA) is issuing a final order to reclassify pedicle screw systems, a preamendments class III device (regulated under product code NKB), into class II (special controls), renaming the device “thoracolumbosacral pedicle screw systems”; reclassify dynamic stabilization systems, a subtype of pedicle screw systems regulated under product code NQP when used as an adjunct to fusion, into class II (special controls), renaming this device subtype “semi-rigid systems”; and clarify the device identification of pedicle screw systems to more clearly delineate between rigid pedicle screw systems and semi-rigid systems. FDA is finalizing this action based on a reevaluation of information pertaining to the device type.
2016-03-10; vol. 81 # 47 - Thursday, March 10, 2016 81 FR 12607 - Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments by June 8, 2016. See section IV of this document for the proposed effective date of a final rule that may issue based on this proposal. 21 CFR Part 888 Summary The Food and Drug Administration (FDA or Agency) is proposing to classify posterior cervical screw systems into class II (special controls) and to continue to require premarket notification to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a prescription device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. The term “posterior cervical screw systems” is used to distinguish these devices from currently classified pedicle screw spinal systems cleared for use in other spinal regions.
2016-02-18; vol. 81 # 32 - Thursday, February 18, 2016 81 FR 8146 - Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective on February 18, 2016. 21 CFR Part 888 Summary The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
2014-11-12; vol. 79 # 218 - Wednesday, November 12, 2014 79 FR 67105 - Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed order. Submit either electronic or written comments on this proposed order by February 10, 2015. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to continue to market dynamic stabilization systems for the specified intended uses listed in section IX will need to file a PMA or a notice of completion of a PDP within 90 days of the effective date of the final order. See section XVII for the proposed effective date of any final order based on this proposed order. 21 CFR Part 888 Summary The Food and Drug Administration (FDA) is proposing in this administrative order to reclassify rigid pedicle screw systems, a preamendments class III device, into class II (special controls); require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the dynamic stabilization systems, currently a subtype of pedicle screws, regardless of the indication for use; and clarify the device identification of pedicle screw spinal systems, to more clearly delineate between rigid pedicle screw systems and dynamic stabilization systems. FDA is proposing this action based on new information pertaining to the device type. This proposed action implements certain statutory requirements.
2013-03-26; vol. 78 # 58 - Tuesday, March 26, 2013 78 FR 18233 - Medical Devices; Technical Amendment
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective March 26, 2013. 21 CFR Parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 Summary The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.
2013-01-18; vol. 78 # 13 - Friday, January 18, 2013 78 FR 4094 - Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed order. Submit either electronic or written comments on the proposed order by April 18, 2013. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to continue to market the device will need to file a PMA or a notice of completion of a PDP within 90 days of the publication of the final order. See section X of this document for the proposed effective date of a final order based on this proposed order. 21 CFR Part 888 Summary The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following two class III preamendments devices: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. This action implements certain statutory requirements.
