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 19-May-2018 03:57
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 872 after this date.
2018-03-14; vol. 83 # 50 - Wednesday, March 14, 2018 83 FR 11144 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective March 14, 2018. The exemption was applicable on January 31, 2018. 21 CFR Part 872 Summary The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. This order exempts OTC denture repair kits, class II devices, from premarket notification (510(k)). This exemption from 510(k) is immediately in effect for OTC denture repair kits. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
2015-11-20; vol. 80 # 224 - Friday, November 20, 2015 80 FR 72585 - Dental Devices; Reclassification of Electrical Salivary Stimulator System
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective December 21, 2015. 21 CFR Part 872 Summary The Food and Drug Administration (FDA) is issuing a final order to reclassify the salivary stimulator system, a postamendments Class III device, into class II (special controls) and to rename the device the “electrical salivary stimulator system.” The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
2014-09-18; vol. 79 # 181 - Thursday, September 18, 2014 79 FR 56027 - Dental Devices; Reclassification of Salivary Stimulatory System, To Be Renamed Electrical Salivary Stimulator System
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed Order. Submit either electronic or written comments by December 17, 2014. Please see section IX of this document for the proposed effective date of any final order that may publish based on this proposed order. 21 CFR Part 872 Summary The Food and Drug Administration (FDA) is proposing to reclassify salivary stimulatory system, a class III device, into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes will provide a reasonable assurance of safety and effectiveness of the device. The Agency is proposing to rename the device “electrical salivary stimulatory system.”
2014-08-25; vol. 79 # 164 - Monday, August 25, 2014 79 FR 50551 - 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 August 25, 2014. 21 CFR Parts 862, 864, 866, and 872 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 correct outdated Web site addresses.
2014-06-18; vol. 79 # 117 - Wednesday, June 18, 2014 79 FR 34623 - Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective July 18, 2014. 21 CFR Part 872 Summary The Food and Drug Administration (FDA) is issuing a final order to reclassify the blade-form endosseous dental implant, a preamendments class III device, into class II (special controls). On its own initiative, based on new information, FDA is revising the classification of blade-form endosseous dental implants.
2013-12-30; vol. 78 # 250 - Monday, December 30, 2013 78 FR 79308 - Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective December 30, 2013. 21 CFR Part 872 Summary The Food and Drug Administration (FDA) is issuing a final order to reclassify temporary mandibular condyle prosthesis, a preamendments class III device, into class II (special controls), and rename the device “temporary mandibular condyle reconstruction plate.” FDA is also issuing the special controls guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline” that sets forth the special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device.
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.
2013-02-07; vol. 78 # 26 - Thursday, February 7, 2013 78 FR 9010 - Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
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 or on the draft guideline by May 8, 2013. See section XIII of this document for the proposed effective date of any final order that may publish based on this proposed order. 21 CFR Part 872 Summary The Food and Drug Administration (FDA) is issuing a proposed order to reclassify temporary mandibular condyle prosthesis, a preamendments class III device, into class II (special controls), and rename the device “temporary mandibular condyle reconstruction plate.” FDA is also issuing the draft special controls guideline, “Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate,” which sets forth the special controls that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device.
2013-01-14; vol. 78 # 9 - Monday, January 14, 2013 78 FR 2647 - Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant
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 April 15, 2013. See section XI of this document for the proposed effective date of a final order based on this proposed order. 21 CFR Part 872 Summary The Food and Drug Administration (FDA) is proposing to reclassify the blade- form endosseous dental implant, a preamendments class III device, into class II (special controls). On its own initiative, based on new information, FDA is proposing to revise the classification of blade-form endosseous dental implants.
