Title 21 published on 2014-04-01
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.
2015-02-03; vol. 80 # 22 - Tuesday, February 3, 2015 80 FR 5674 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems; Republication
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order; republication. This order is effective on February 3, 2015. 21 CFR Part 870 Summary The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled “Effective Date of Requirement for Premarket Approval for Automated External Defibrillator” that published in the Federal Register on January 29, 2015 (80 FR 4783). FDA is republishing to correct an inadvertent omission of a comment regarding adverse tissue reaction as a risk to health and the Agency's response to that comment. The final order requires the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock ( e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use).
2015-01-29; vol. 80 # 19 - Thursday, January 29, 2015 80 FR 4783 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective on January 29, 2015. 21 CFR Part 870 Summary The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock ( e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use).
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.
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United States Code U.S. Code: Title 21 - FOOD AND DRUGS
Title 21 published on 2014-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 870 after this date.
2015-02-03; vol. 80 # 22 - Tuesday, February 3, 2015 80 FR 5674 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems; Republication
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order; republication. This order is effective on February 3, 2015. 21 CFR Part 870 Summary The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled “Effective Date of Requirement for Premarket Approval for Automated External Defibrillator” that published in the Federal Register on January 29, 2015 (80 FR 4783). FDA is republishing to correct an inadvertent omission of a comment regarding adverse tissue reaction as a risk to health and the Agency's response to that comment. The final order requires the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock ( e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use).
2015-01-29; vol. 80 # 19 - Thursday, January 29, 2015 80 FR 4783 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective on January 29, 2015. 21 CFR Part 870 Summary The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock ( e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use).
2014-09-15; vol. 79 # 178 - Monday, September 15, 2014 79 FR 54927 - Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers
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 December 15, 2014. See section XII for the effective date of any final order that may publish based on this proposed order. 21 CFR Part 870 Summary The Food and Drug Administration (FDA) is proposing in this administrative order to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls), and to amend the device identification and reclassify the pacing system analyzers (PSAs) into class II (special controls). Specifically, single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are postamendments class III devices, are proposed to be reclassified to class II devices. FDA is proposing this reclassification based on new information pertaining to the device. This proposed action would implement certain statutory requirements.
79 FR 54927 - Cardiovascular Devices; Withdrawal of Proposed Rule of Reclassification of External Pacemaker Pulse Generator Devices
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; withdrawal. The proposed rule is withdrawn on September 15, 2014. 21 CFR Part 870 Summary The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of October 17, 2011. In that document, FDA proposed to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls). In response to the requirements under the Food and Drug Administration Safety and Innovation Act (FDASIA) and new information received during a panel meeting, FDA is withdrawing the proposed rule and issuing a proposed administrative order to reclassify EPPGs.
