{"abstract":"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.","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2012/07/06/2012-16487.html","cfr_references":[{"chapter":null,"citation_url":null,"part":890,"title":21}],"citation":"77 FR 39953","comment_url":null,"comments_close_on":"2012-10-04","correction_of":null,"corrections":[],"dates":"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.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0378"],"dockets":[],"document_number":"2012-16487","effective_on":null,"end_page":39959,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/07/06/2012-16487.xml","html_url":"https://www.federalregister.gov/documents/2012/07/06/2012-16487/effective-date-of-requirement-for-premarket-approval-for-shortwave-diathermy-for-all-other-uses","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-16487?publication_date=2012-07-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-07-06/2012-16487/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":1672,"last_updated":"2026-06-24 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-07-06/pdf/2012-16487.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-16487.pdf?1341492604","publication_date":"2012-07-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/07/06/2012-16487.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-0378","supporting_documents_count":0,"docket_id":"FDA-2012-N-0378","regulation_id_number":null,"title":"Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses","checked_regulationsdotgov_at":"2012-10-06T05:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":39953,"subtype":null,"title":"Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses","toc_doc":"Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses; Effective Date","toc_subject":null,"topics":["Medical devices"],"type":"Proposed Rule","volume":77}