{"abstract":"The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I 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/2018/10/19/2018-22837.html","cfr_references":[{"chapter":null,"citation_url":null,"part":878,"title":21}],"citation":"83 FR 52966","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective October 19, 2018. The classification was applicable on July 31, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-3696"],"dockets":[],"document_number":"2018-22837","effective_on":"2018-10-19","end_page":52968,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/10/19/2018-22837.xml","html_url":"https://www.federalregister.gov/documents/2018/10/19/2018-22837/medical-devices-general-and-plastic-surgery-devices-classification-of-the-wound-autofluorescence","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-22837?publication_date=2018-10-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-10-19/2018-22837/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":494,"last_updated":"2026-09-22 20:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-10-19/pdf/2018-22837.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-22837.pdf?1539866734","publication_date":"2018-10-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/10/19/2018-22837.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-3696","supporting_documents_count":0,"docket_id":"FDA-2018-N-3696","regulation_id_number":null,"title":"Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device","checked_regulationsdotgov_at":"2018-11-08T11:00:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52966,"subtype":null,"title":"Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device","toc_doc":"General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":83}