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.
2015-11-20; vol. 80 # 224 - Friday, November 20, 2015 80 FR 72589 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective November 20, 2015. 21 CFR Part 890 Summary The Food and Drug Administration (FDA or the Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for electric positioning chair devices. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. These devices are used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. This order exempts electric positioning chairs, class II devices, from premarket notification, subject to certain conditions for exemption. This exemption from premarket notification, subject to these conditions (and the limitations in the physical medicine devices limitations of exemptions from premarket notification section of the device regulations), is immediately in effect for electric positioning chairs. FDA is publishing this order in accordance with the exemption from class II premarket notification section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
2015-10-13; vol. 80 # 197 - Tuesday, October 13, 2015 80 FR 61298 - Physical Medicine Devices; Reclassification of Shortwave Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal Shortwave Therapy
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order; technical correction. This order is effective on October 13, 2015. See further discussion in Section IV, “Implementation Strategy.” 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is issuing a final order to reclassify shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device “nonthermal shortwave therapy” (SWT). FDA is also making a technical correction in the regulation for the carrier frequency for SWD and SWT devices.
2015-05-04; vol. 80 # 85 - Monday, May 4, 2015 80 FR 25226 - Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton; Republication
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order; republication. This order is effective May 4, 2015. The classification was applicable on June 26, 2014. 21 CFR Part 890 Summary The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled “Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton” that published in the Federal Register on February 24, 2015. FDA is republishing to correct an inadvertent omission of information. FDA is classifying the powered lower extremity exoskeleton 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 powered lower extremity exoskeleton'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.
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 890 after this date.
2015-11-20; vol. 80 # 224 - Friday, November 20, 2015 80 FR 72589 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective November 20, 2015. 21 CFR Part 890 Summary The Food and Drug Administration (FDA or the Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for electric positioning chair devices. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. These devices are used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. This order exempts electric positioning chairs, class II devices, from premarket notification, subject to certain conditions for exemption. This exemption from premarket notification, subject to these conditions (and the limitations in the physical medicine devices limitations of exemptions from premarket notification section of the device regulations), is immediately in effect for electric positioning chairs. FDA is publishing this order in accordance with the exemption from class II premarket notification section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
2015-10-13; vol. 80 # 197 - Tuesday, October 13, 2015 80 FR 61298 - Physical Medicine Devices; Reclassification of Shortwave Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal Shortwave Therapy
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order; technical correction. This order is effective on October 13, 2015. See further discussion in Section IV, “Implementation Strategy.” 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is issuing a final order to reclassify shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device “nonthermal shortwave therapy” (SWT). FDA is also making a technical correction in the regulation for the carrier frequency for SWD and SWT devices.
2015-05-04; vol. 80 # 85 - Monday, May 4, 2015 80 FR 25226 - Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton; Republication
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order; republication. This order is effective May 4, 2015. The classification was applicable on June 26, 2014. 21 CFR Part 890 Summary The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled “Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton” that published in the Federal Register on February 24, 2015. FDA is republishing to correct an inadvertent omission of information. FDA is classifying the powered lower extremity exoskeleton 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 powered lower extremity exoskeleton'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.
