{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff.\" This guidance document is intended to assist industry and FDA staff in identifying and appropriately addressing specific considerations related to the incorporation and integration of radio frequency (RF) wireless technology in medical devices. This guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility, and provides recommendations for information to be included in FDA premarket submissions for such devices.","action":"Notice.","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/2013/08/14/2013-19686.html","cfr_references":[],"citation":"78 FR 49529","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2006-D-0300"],"dockets":[],"document_number":"2013-19686","effective_on":null,"end_page":49530,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/08/14/2013-19686.xml","html_url":"https://www.federalregister.gov/documents/2013/08/14/2013-19686/radio-frequency-wireless-technology-in-medical-devices-guidance-for-industry-and-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-19686?publication_date=2013-08-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-08-14/2013-19686/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":732,"last_updated":"2026-10-24 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-08-14/pdf/2013-19686.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-19686.pdf?1376398231","publication_date":"2013-08-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/08/14/2013-19686.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Guidance","document_id":"FDA-2006-D-0300-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2006-D-0300","supporting_documents_count":1,"docket_id":"FDA-2006-D-0300","regulation_id_number":null,"title":"Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices","checked_regulationsdotgov_at":"2013-09-03T06:00:15Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":49529,"subtype":null,"title":"Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Radio Frequency Wireless Technology in Medical Devices","toc_subject":"Guidance for Industry and Food and Drug Administration Staff; Availability:","topics":[],"type":"Notice","volume":78}