{"abstract":"The Food and Drug Administration (FDA) is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, \"non-invasive bone growth stimulator.\" FDA is also establishing the special controls necessary to provide reasonable assurance of safety and effectiveness of these devices.","action":"Final amendment; final order.","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/2026/04/16/2026-07366.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"890","title":21}],"citation":"91 FR 20352","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective May 18, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-1053"],"dockets":[{"supporting_documents":[{"title":"Reference 12 - Yasuda published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0033"},{"title":"Reference 15 - Dwyer published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0032"},{"title":"Reference 31 - Mizra published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0031"},{"title":"Referece 34 - Assiotis published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0029"},{"title":"Reference 36 - Foley published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0028"},{"title":"Reference 39 - Behrens published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0027"},{"title":"Reference 42 - Hannemann published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0024"},{"title":"Reference 27 - Zura published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0023"},{"title":"Reference 29 - Elvey published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0021"},{"title":"Reference 30 - Majeed published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0020"}],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-04-16T14:03:37.226-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-1053-0041","allow_late_comments":false,"id":"FDA-2020-N-1053-0041","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":32,"id":"FDA-2020-N-1053","title":"Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators"}],"document_number":"2026-07366","effective_on":"2026-05-18","end_page":20362,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/04/16/2026-07366.xml","html_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-07366?publication_date=2026-04-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-04-16/2026-07366/mods.xml","not_received_for_publication":null,"page_length":11,"page_views":{"count":667,"last_updated":"2026-04-17 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/2026-07366.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07366.pdf?1776257113","publication_date":"2026-04-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/04/16/2026-07366.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 12 - Yasuda published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0033"},{"title":"Reference 15 - Dwyer published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0032"},{"title":"Reference 31 - Mizra published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0031"},{"title":"Referece 34 - Assiotis published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0029"},{"title":"Reference 36 - Foley published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0028"},{"title":"Reference 39 - Behrens published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0027"},{"title":"Reference 42 - Hannemann published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0024"},{"title":"Reference 27 - Zura published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0023"},{"title":"Reference 29 - Elvey published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0021"},{"title":"Reference 30 - Majeed published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","document_id":"FDA-2020-N-1053-0020"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-1053","supporting_documents_count":32,"docket_id":"FDA-2020-N-1053","document_id":"FDA-2020-N-1053-0041","regulation_id_number":null,"title":"Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","checked_regulationsdotgov_at":"2026-04-17T10:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20352,"subtype":null,"title":"Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","toc_doc":"Reclassification of Non-Invasive Bone Growth Stimulators","toc_subject":"Physical Medicine Devices","topics":["Medical devices"],"type":"Rule","volume":91}