{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled \"Pediatric Information for X-ray Imaging Device Premarket Notifications.\" This guidance document outlines FDA's current thinking on information that should be provided in premarket notification submissions for x-ray imaging devices that are indicated for pediatric populations or general use x-ray imaging devices for which considerable pediatric application is anticipated. FDA intends for this guidance to minimize uncertainty during the premarket review process of premarket notification submissions for x- ray imaging devices for pediatric use to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notification submissions and to provide recommendations on information to support such indications. Both new devices and modifications of existing x-ray imaging devices that require submission of a new premarket notification are included within the scope of this guidance document, regardless of whether the device is a complete x-ray imaging system, a component part of an x-ray imaging device, or an accessory (e.g., detectors and software).","action":"Notice of availability.","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/2017/11/28/2017-25632.html","cfr_references":[],"citation":"82 FR 56248","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on November 28, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0384"],"dockets":[],"document_number":"2017-25632","effective_on":null,"end_page":56250,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/11/28/2017-25632.xml","html_url":"https://www.federalregister.gov/documents/2017/11/28/2017-25632/pediatric-information-for-x-ray-imaging-device-premarket-notifications-guidance-for-industry-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-25632?publication_date=2017-11-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-11-28/2017-25632/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":206,"last_updated":"2026-08-25 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-11-28/pdf/2017-25632.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-25632.pdf?1511790356","publication_date":"2017-11-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/11/28/2017-25632.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-D-0384","supporting_documents_count":0,"docket_id":"FDA-2012-D-0384","regulation_id_number":null,"title":"Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-ray Imaging Device Premarket Notifications; Availability","checked_regulationsdotgov_at":"2017-12-18T06:00:28Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56248,"subtype":null,"title":"Pediatric Information for X-Ray Imaging Device Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Pediatric Information for X-ray Imaging Device Premarket Notifications","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":82}