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 09-Jun-2018 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 890 after this date.
2018-04-02; vol. 83 # 63 - Monday, April 2, 2018 83 FR 13863 - 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 April 2, 2018. 21 CFR Parts 890, 900, 1020, and 1040 Summary The Food and Drug Administration (FDA or Agency) is amending certain medical device regulations. This action is editorial in nature to correct typographical errors and to ensure accuracy and clarity in the Agency's regulations.
2016-10-18; vol. 81 # 201 - Tuesday, October 18, 2016 81 FR 71610 - Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective October 18, 2016. The classification was applicable on May 9, 2014. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is classifying the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components 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 upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components' 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.
2016-07-26; vol. 81 # 143 - Tuesday, July 26, 2016 81 FR 48703 - Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective on July 26, 2016. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification.
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.
2015-02-24; vol. 80 # 36 - Tuesday, February 24, 2015 80 FR 9600 - Medical Devices; Physical Medicine Devices; Classification of the Powered Exoskeleton
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective March 26, 2015. The classification was applicable on June 26, 2014. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is classifying the powered 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 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.
2014-09-22; vol. 79 # 183 - Monday, September 22, 2014 79 FR 56532 - Reclassification of Iontophoresis Devices Intended for Any Other Purposes
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed order. Submit either electronic or written comments by December 22, 2014. See section XII for the proposed effective date of a final order based on this proposed order. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is proposing to reclassify iontophoresis devices intended for any other purposes, a preamendments class III device, into class II (special controls), and to amend the device identification. FDA is proposing this reclassification on its own initiative based on new information. This action implements certain statutory requirements.
2014-07-03; vol. 79 # 128 - Thursday, July 3, 2014 79 FR 37948 - Medical Devices; Physical Medicine Devices; Classification of the Nonpowered Lower Extremity Pressure Wrap
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 December 18, 2013. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is classifying the nonpowered lower extremity pressure wrap into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
2014-04-14; vol. 79 # 71 - Monday, April 14, 2014 79 FR 20779 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective April 14, 2014. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is issuing a final order to reclassify stair-climbing wheelchairs, a class III device, into class II (special controls) based on new information and subject to premarket notification, and further clarify the identification.
2014-02-20; vol. 79 # 34 - Thursday, February 20, 2014 79 FR 9670 - Physical Medicine Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses
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 February 20, 2014. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of July 6, 2012. In that document, 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, shortwave diathermy (SWD) for all other uses. In response to the requirements issued in 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 proposing a different action.
79 FR 9671 - Physical Medicine Devices; Reclassification and Renaming of Shortwave Diathermy for All Other Uses
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed order; technical correction. Submit either electronic or written comments on this proposed order by May 21, 2014. February 21, 2014FDA intends that SWD devices for all other uses must comply with the special controls and must submit a premarket notification (510(k)) within 60 days after the effective date of the final order. See Section XII for the proposed effective date of a final order based on this proposed order. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is proposing to reclassify the 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 proposing this reclassification on its own initiative based on new information. FDA is also proposing a technical correction in the regulation for the carrier frequency for SWD and nonthermal SWT devices. This proposed action would implement certain regulatory requirements.
2013-07-02; vol. 78 # 127 - Tuesday, July 2, 2013 78 FR 39649 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed order; correction. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is correcting a proposed order that appeared in the Federal Register of June 12, 2013 (78 FR 35173). The document proposed to reclassify stair-climbing wheelchairs. The document was published with typographical errors in the DATES section of the document. This document corrects those errors.
2013-06-12; vol. 78 # 113 - Wednesday, June 12, 2013 78 FR 35173 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs
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 or on the draft guideline by September 10, 2013. See section XII for the proposed effective date of any final order that may publish based on this proposed order. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify stair-climbing wheelchairs, a class III device, into class II (special controls) based on new information and subject to premarket notification, and to further clarify the identification.
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.
2013-03-04; vol. 78 # 42 - Monday, March 4, 2013 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective March 4, 2013. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective March 4, 2013. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for powered patient transport devices commonly known as stairway chair lifts. These devices are used to assist in the transfer of a person with a mobility impairment caused by injury or other disease up and down flights of stairs. This order exempts stairway chair lifts, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for stairway chair lifts. All other devices classified under FDA's powered patient transport regulations, including attendant-operated portable stair-climbing chairs (which are different from wheelchairs) continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
2012-07-06; vol. 77 # 130 - Friday, July 6, 2012 77 FR 39953 - Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses
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 October 4, 2012. Submit requests for a change in classification by July 23, 2012. FDA intends that, if a final rule based on this proposed rule is issued, anyone who wishes to continue to market the device will need to submit a PMA or a notice of completion of a PDP within 90 days of the effective date of the final rule. Please see section XII of this document for the proposed effective date of any final rule that may publish based on this proposal. 21 CFR Part 890 Summary The Food and Drug Administration (FDA) is proposing 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 preamendments device, shortwave diathermy (SWD) for all other uses. This device applies to the body electromagnetic energy in the radio frequency bands of 13 megahertz to 27.12 megahertz and is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues. It is not intended for treatment of malignancies. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. This action implements certain statutory requirements.
