Title 21 published on 2015-04-01 .
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
2015-10-21; vol. 80 # 203 - Wednesday, October 21, 2015 80 FR 63671 - Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective October 21, 2015. The classification was applicable on November 26, 2014. 21 CFR Part 870 Summary The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device 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 coronary vascular physiologic simulation software device'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.
2015-09-30; vol. 80 # 189 - Wednesday, September 30, 2015 80 FR 58603 - Medical Devices; Cardiovascular Devices; Classification of the Steerable Cardiac Ablation Catheter Remote Control System
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective September 30, 2015. The classification was applicable on December 18, 2014. 21 CFR Part 870 Summary The Food and Drug Administration (FDA) is classifying the steerable cardiac ablation catheter remote control 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 steerable cardiac ablation catheter remote control 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.
2015-08-18; vol. 80 # 159 - Tuesday, August 18, 2015 80 FR 49895 - Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective August 18, 2015. The classification was applicable on June 23, 2015. 21 CFR Part 870 Summary The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device 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 esophageal thermal regulation device'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.
2015-06-08; vol. 80 # 109 - Monday, June 8, 2015 80 FR 32307 - Cardiovascular Devices; Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; Effective Date of Requirement for Premarket Approval for Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary Ventricular Support
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective June 8, 2015. 21 CFR Part 870 Summary The Food and Drug Administration (FDA) is issuing a final order to reclassify nonroller-type cardiopulmonary bypass blood pump (NRP) devices for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) for NRP devices for temporary ventricular support. FDA is also revising the title and identification of the regulation for NRP devices in this order.
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 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 870 after this date.
2015-10-21; vol. 80 # 203 - Wednesday, October 21, 2015 80 FR 63671 - Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective October 21, 2015. The classification was applicable on November 26, 2014. 21 CFR Part 870 Summary The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device 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 coronary vascular physiologic simulation software device'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.
2015-09-30; vol. 80 # 189 - Wednesday, September 30, 2015 80 FR 58603 - Medical Devices; Cardiovascular Devices; Classification of the Steerable Cardiac Ablation Catheter Remote Control System
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective September 30, 2015. The classification was applicable on December 18, 2014. 21 CFR Part 870 Summary The Food and Drug Administration (FDA) is classifying the steerable cardiac ablation catheter remote control 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 steerable cardiac ablation catheter remote control 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.
2015-08-18; vol. 80 # 159 - Tuesday, August 18, 2015 80 FR 49895 - Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective August 18, 2015. The classification was applicable on June 23, 2015. 21 CFR Part 870 Summary The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device 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 esophageal thermal regulation device'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.
2015-06-08; vol. 80 # 109 - Monday, June 8, 2015 80 FR 32307 - Cardiovascular Devices; Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; Effective Date of Requirement for Premarket Approval for Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary Ventricular Support
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective June 8, 2015. 21 CFR Part 870 Summary The Food and Drug Administration (FDA) is issuing a final order to reclassify nonroller-type cardiopulmonary bypass blood pump (NRP) devices for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) for NRP devices for temporary ventricular support. FDA is also revising the title and identification of the regulation for NRP devices in this order.
