{"abstract":"The Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the extracorporeal shock wave device for treatment of chronic wounds' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","action":"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/2018/03/07/2018-04616.html","cfr_references":[{"chapter":null,"citation_url":null,"part":878,"title":21}],"citation":"83 FR 9698","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective March 7, 2018. The classification was applicable on December 28, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-0387"],"dockets":[],"document_number":"2018-04616","effective_on":"2018-03-07","end_page":9700,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/03/07/2018-04616.xml","html_url":"https://www.federalregister.gov/documents/2018/03/07/2018-04616/medical-devices-general-and-plastic-surgery-devices-classification-of-the-extracorporeal-shock-wave","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-04616?publication_date=2018-03-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-03-07/2018-04616/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2223,"last_updated":"2026-07-28 16:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-03-07/pdf/2018-04616.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-04616.pdf?1520343923","publication_date":"2018-03-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/03/07/2018-04616.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-2018-N-0387","supporting_documents_count":0,"docket_id":"FDA-2018-N-0387","regulation_id_number":null,"title":"Medical Devices; General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds.","checked_regulationsdotgov_at":"2018-03-27T10:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9698,"subtype":null,"title":"Medical Devices; General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds","toc_doc":"General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":83}