Source: http://www.law.cornell.edu/cfr/text/21/890
Timestamp: 2013-12-20 20:03:54
Document Index: 465876944

Matched Legal Cases: ['art 890', 'art 890', 'art 890', '§ 890', '§ 890', '§ 890', '§ 890', 'art 890', 'art 890', 'art 890', 'art 890', 'art 890', 'art 890']

21 CFR Part 890 - PHYSICAL MEDICINE DEVICES | Title 21 - Food and Drugs | Code of Federal Regulations | LII / Legal Information Institute
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21 CFR Part 890 - PHYSICAL MEDICINE DEVICES
There are 3 Updates appearing in the Federal Register for 21 CFR 890. Select the tab below to view, or View eCFR (GPOAccess)
SUBPART A — General Provisions (§§ 890.1 - 890.9)
SUBPART B — Physical Medicine Diagnostic Devices (§§ 890.1175 - 890.1925)
SUBPART D — Physical Medicine Prosthetic Devices (§§ 890.3025 - 890.3940)
SUBPART F — Physical Medicine Therapeutic Devices (§§ 890.5050 - 890.5975)
48 FR 53047, Nov. 23, 1983, unless otherwise noted.
Nomenclature changes to part 890 appear at 73 FR 35341, June 23, 2008.
2013-03-04; vol. 78 # 42 - Monday, March 4, 201378 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator
typeregulations.gov FR Doc.2013-04899 RIN Docket No.FDA-2011-P-0882 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective March 4, 2013. 21 CFR Part 890 SummaryThe 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&apos;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
typeregulations.gov FR Doc.2013-04897 RIN Docket No.FDA-2011-P-0804 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective March 4, 2013. 21 CFR Part 890 SummaryThe 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&apos;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).
Title 21 published on 2012-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 890 after this date.2013-07-02; vol. 78 # 127 - Tuesday, July 2, 201378 FR 39649 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs; Correction
typeregulations.gov FR Doc.2013-15789 RIN Docket No.FDA-2013-N-0568 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed order; correction. 21 CFR Part 890 SummaryThe 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, 201378 FR 35173 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs
typeregulations.gov FR Doc.2013-13864 RIN Docket No.FDA-2013-N-0568 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 SummaryThe 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.
2012-07-06; vol. 77 # 130 - Friday, July 6, 201277 FR 39953 - Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses
typeregulations.gov FR Doc.2012-16487 RIN Docket No.FDA-2012-N-0378 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 SummaryThe 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&apos;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.