{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Pediatric Information for X-ray Imaging Device Premarket Notifications.\" This draft guidance document outlines FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations on information to support such indications. This draft guidance applies only to complete x-ray imaging devices that could be used on pediatric patients. This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human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/2012/05/10/2012-11260.html","cfr_references":[],"citation":"77 FR 27461","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 7, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0384"],"dockets":[],"document_number":"2012-11260","effective_on":null,"end_page":27463,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/05/10/2012-11260.xml","html_url":"https://www.federalregister.gov/documents/2012/05/10/2012-11260/draft-guidance-for-industry-and-food-and-drug-administration-staff-pediatric-information-for-x-ray","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-11260?publication_date=2012-05-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-05-10/2012-11260/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":145,"last_updated":"2026-07-26 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-05-10/pdf/2012-11260.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-11260.pdf?1336567778","publication_date":"2012-05-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/05/10/2012-11260.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":"2012-05-30T08:10:40Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27461,"subtype":null,"title":"Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability","toc_doc":"Pediatric Information for X-Ray Imaging Device Premarket Notifications","toc_subject":"Draft Guidance for Industry and Food and Drug Administration Staff; Availability:","topics":[],"type":"Notice","volume":77}