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 878 after this date.
2018-05-17; vol. 83 # 96 - Thursday, May 17, 2018 83 FR 22846 - Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective May 17, 2018. 21 CFR Part 878 Summary The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. This exemption will decrease regulatory burden on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. All other class II devices classified under FDA's surgical apparel classification regulation continue to be subject to premarket notification requirements. FDA is also amending the codified language for the surgical apparel devices classification regulation to reflect this final determination.
2018-03-07; vol. 83 # 45 - Wednesday, March 7, 2018 83 FR 9698 - Medical Devices; General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective March 7, 2018. The classification was applicable on December 28, 2017. 21 CFR Part 878 Summary The Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the extracorporeal shock wave device for treatment of chronic wounds' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2018-02-15; vol. 83 # 32 - Thursday, February 15, 2018 83 FR 6793 - Medical Devices; General and Plastic Surgery Devices; Classification of the Non-Absorbable, Hemostatic Gauze for Temporary Internal Use
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective February 15, 2018. The classification was applicable on June 30, 2017. 21 CFR Part 878 Summary The Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-absorbable, hemostatic gauze for temporary internal use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2018-01-30; vol. 83 # 20 - Tuesday, January 30, 2018 83 FR 4141 - Medical Devices; General and Plastic Surgery Devices; Classification of the Surgical Smoke Precipitator
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective January 30, 2018. The classification was applicable on December 20, 2016. 21 CFR Part 878 Summary The Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the surgical smoke precipitator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2018-01-02; vol. 83 # 1 - Tuesday, January 2, 2018 83 FR 22 - Medical Devices; General and Plastic Surgery Devices; Classification of the Irrigating Wound Retractor Device
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective January 2, 2018. The classification was applicable on December 16, 2016. 21 CFR Part 878 Summary The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the irrigating wound retractor device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2017-11-30; vol. 82 # 229 - Thursday, November 30, 2017 82 FR 56763 - Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel; Request for Comments
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed order; request for comments. Submit either electronic or written comments by January 29, 2018. 21 CFR Part 878 Summary The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA intends to limit the proposed exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. All other class II devices classified under FDA's surgical apparel classification regulation would continue to be subject to premarket notification requirements. FDA is publishing this document to obtain comments regarding this proposed exemption, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2016-12-19; vol. 81 # 243 - Monday, December 19, 2016 81 FR 91722 - Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective on January 18, 2017. 21 CFR Parts 878, 880, and 895 Summary The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.
2016-09-21; vol. 81 # 183 - Wednesday, September 21, 2016 81 FR 64761 - Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective September 21, 2016. The classification was applicable on June 13, 2016. 21 CFR Part 878 Summary The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the magnetic surgical instrument system's classification. 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.
2016-06-29; vol. 81 # 125 - Wednesday, June 29, 2016 81 FR 42243 - Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective June 29, 2016. The classification was applicable on December 18, 2015. 21 CFR Part 878 Summary The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the electrosurgical device for over-the-counter aesthetic use's classification. 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.
2016-03-22; vol. 81 # 55 - Tuesday, March 22, 2016 81 FR 15173 - Banned Devices; Proposal To Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove
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 20, 2016. 21 CFR Parts 878, 880, and 895 Summary The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is proposing these devices be banned.
2016-03-03; vol. 81 # 42 - Thursday, March 3, 2016 81 FR 11140 - General and Plastic Surgery Devices; Reclassification of Blood Lancets
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 June 1, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by April 4, 2016, (see the “Paperwork Reduction Act of 1995” section of this document). See section X of the SUPPLEMENTARY INFORMATION section of this document for the proposed effective date of any final order that may publish based on this proposal. 21 CFR Part 878 Summary The Food and Drug Administration (FDA or the Agency) is proposing to reclassify the following three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket review: Single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is identifying proposed special controls for these types of blood lancets that we believe are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also proposing to reclassify multiple use blood lancets for multiple patient use from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is proposing the reclassification of these four types of blood lancets on its own initiative based on new information.
81 FR 11151 - Effective Date of Requirement for Premarket Approval for Blood Lancets
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 June 1, 2016. See section X of the SUPPLEMENTARY INFORMATION section of this document for the proposed effective date of any final order that may publish based on this proposal. 21 CFR Part 878 Summary The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III. FDA is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the PMA requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the benefits to the public from the use of the device.
2016-02-12; vol. 81 # 29 - Friday, February 12, 2016 81 FR 7452 - Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective February 12, 2016. The classification was applicable on December 8, 2015. 21 CFR Part 878 Summary The Food and Drug Administration (FDA) is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia's classification. 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.
2015-12-22; vol. 80 # 245 - Tuesday, December 22, 2015 80 FR 79493 - General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by March 21, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 22, 2016. See Section VIII for the proposed effective date of a final rule based on this proposed rule. 21 CFR Part 878 Summary The Food and Drug Administration (FDA or the Agency) is proposing to establish device restrictions for sunlamp products, which would restrict their use to individuals age 18 and older, require prospective users to sign a risk acknowledgement certification before use, and require the provision of user manuals.
2015-08-05; vol. 80 # 150 - Wednesday, August 5, 2015 80 FR 46485 - Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective August 5, 2015. The classification was applicable on December 18, 2014. 21 CFR Part 878 Summary The Food and Drug Administration (FDA) is classifying the internal tissue marker into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the internal tissue marker's classification. 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.
2014-06-16; vol. 79 # 115 - Monday, June 16, 2014 79 FR 34222 - Medical Devices; General and Plastic Surgery Devices; Classification of the Nonabsorbable Expandable Hemostatic Sponge for Temporary Internal Use
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective July 16, 2014. The classification was applicable April 3, 2014. 21 CFR Part 878 Summary The Food and Drug Administration (FDA) is classifying the nonabsorbable expandable hemostatic sponge for temporary internal use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the nonabsorbable expandable hemostatic sponge for temporary internal use classification. 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.
2014-06-03; vol. 79 # 106 - Tuesday, June 3, 2014 79 FR 31859 - Medical Devices; General and Plastic Surgery Devices; Classification of the Powered Surgical Instrument for Improvement in the Appearance of Cellulite
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective July 3, 2014. The classification was applicable on July 12, 2013. 21 CFR Part 878 Summary The Food and Drug Administration (FDA) is classifying the powered surgical instrument for improvement in the appearance of cellulite into class II (special controls). 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.
2014-06-02; vol. 79 # 105 - Monday, June 2, 2014 79 FR 31205 - General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final Order. This order is effective September 2, 2014. See further discussion in section V “Implementation Strategy” for compliance dates. 21 CFR Part 878 Summary The Food and Drug Administration (FDA or the Agency) is reclassifying ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and renaming them sunlamp products and UV lamps intended for use in sunlamp products. FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.
2014-03-10; vol. 79 # 46 - Monday, March 10, 2014 79 FR 13218 - Medical Devices; General and Plastic Surgery Devices; Classification of the Absorbable Lung Biopsy Plug
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective April 9, 2014. The classification was effective on December 19, 2012. 21 CFR Part 878 Summary The Food and Drug Administration (FDA) is classifying the absorbable lung biopsy plug into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the absorbable lung biopsy plug's classification. 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.
2013-05-09; vol. 78 # 90 - Thursday, May 9, 2013 78 FR 27117 - General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products
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 August 7, 2013. See section XI for the proposed effective date of a final order based on this proposed order. 21 CFR Part 878 Summary The Food and Drug Administration (FDA) is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. FDA is also designating special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information.
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.
