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.
2014-07-08; vol. 79 # 130 - Tuesday, July 8, 2014 79 FR 38457 - Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective August 7, 2014. The classification was applicable on December 13, 2013. 21 CFR Part 882 Summary The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache 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 transcranial magnetic stimulator for headache 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.
2014-07-03; vol. 79 # 128 - Thursday, July 3, 2014 79 FR 37946 - Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Headache
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective August 4, 2014. The classification was applicable on March 11, 2014. 21 CFR Part 882 Summary The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache 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 transcutaneous electrical nerve stimulator to treat headache 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.
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 882 after this date.
2014-07-08; vol. 79 # 130 - Tuesday, July 8, 2014 79 FR 38457 - Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective August 7, 2014. The classification was applicable on December 13, 2013. 21 CFR Part 882 Summary The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache 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 transcranial magnetic stimulator for headache 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.
2014-07-03; vol. 79 # 128 - Thursday, July 3, 2014 79 FR 37946 - Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Headache
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective August 4, 2014. The classification was applicable on March 11, 2014. 21 CFR Part 882 Summary The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache 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 transcutaneous electrical nerve stimulator to treat headache 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.
2014-06-12; vol. 79 # 113 - Thursday, June 12, 2014 79 FR 33712 - Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Withdrawal of proposed rule and proposed order. The proposed rule and the proposed order, in part, are withdrawn on June 12, 2014. 21 CFR Part 882 Summary The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of August 8, 2011, and the proposed order the Agency issued in the Federal Register of April 4, 2013, in part. In those documents, FDA proposed to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendment device, cranial electrotherapy stimulator (CES). In response to information received in response to these two proposed actions, FDA is withdrawing the proposed rule and proposed order.
