United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2012_register executive 2012-07-06 article Proposed Rules D09002ee1c7fcc545 D09002ee1c7fcc5bc United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 77 FR 39953 https://www.govinfo.gov/app/details/FR-2012-07-06/2012-16487 2012-16487 fr06jy12-11 4160-01-P Docket No. FDA-2012-N-0378 https://www.govinfo.gov/app/details/FR-2012-07-06/2012-16487 https://www.govinfo.gov/content/pkg/FR-2012-07-06/html/2012-16487.htm https://www.govinfo.gov/content/pkg/FR-2012-07-06/pdf/2012-16487.pdf Medical Devices Physical Medicine Devices 7 p. 39953 39959 77 FR 39953 Title 21 Part 890 21 CFR Part 890 Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses; Federal Register Vol. 77, Issue PRORULE 2012-16487 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2012-10-04 Docket No. FDA-2012-N-0378 4160-01-P 2012-16487 Proposed rule.

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.

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. Michael J. Ryan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1615, Silver Spring, MD 20993, 301-796- 6283. Medical Devices Physical Medicine Devices Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses; Effective Date , http://circ.ahajournals.org/content/109/25/3068.full http://iopscience.iop.org/0143-0815/11/1/005 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/PSN/printer.cfm?id=22 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109216.pdf.2005 http://www.fda.gov/ohrms/dockets/ac/cdrh03.html http://www.medicaldevices.org http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2751455/ http://www.regulations.gov http://www.sba.gov/sites/default/files/Size_Standards_Table.pdf http://www.woundsresearch.com/article/300 Vol. 77, no. 130 Office of the Federal Register, National Archives and Records Administration 2012-07-06 continuing daily deposited born digital 361 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-07-06 P0b002ee182a6e798 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr06jy12 https://www.govinfo.gov/app/details/FR-2012-07-06 https://www.govinfo.gov/content/pkg/FR-2012-07-06/pdf/FR-2012-07-06.pdf https://www.govinfo.gov/content/pkg/FR-2012-07-06/xml/FR-2012-07-06.xml fdlp 39895 40247 DGPO 2012-07-06 2024-06-03 FR-2012-07-06 machine generated eng FR FR-2012-07-06 77 130