{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions.\" FDA is issuing this guidance to provide recommendations for manufacturers about the information that should be included in premarket submissions for radiological devices that include quantitative imaging functions. This guidance document is broadly applicable to a variety of premarket submission types (i.e., premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests) for these devices and should be used in conjunction with existing device- and submission-specific guidance documents.","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/2022/06/16/2022-12930.html","cfr_references":[],"citation":"87 FR 36332","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 16, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-1470"],"dockets":[],"document_number":"2022-12930","effective_on":null,"end_page":36334,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/06/16/2022-12930.xml","html_url":"https://www.federalregister.gov/documents/2022/06/16/2022-12930/technical-performance-assessment-of-quantitative-imaging-in-radiological-device-premarket","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-12930?publication_date=2022-06-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-06-16/2022-12930/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":499,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-06-16/pdf/2022-12930.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-12930.pdf?1655297113","publication_date":"2022-06-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/06/16/2022-12930.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2019-D-1470-0009"},{"title":"Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2019-D-1470-0008"},{"title":"Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2019-D-1470-0002"},{"title":"Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff","document_id":"FDA-2019-D-1470-0001"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-D-1470","supporting_documents_count":4,"docket_id":"FDA-2019-D-1470","document_id":"FDA-2019-D-1470-0008","regulation_id_number":null,"title":"Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2022-06-17T03:30:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":36332,"subtype":null,"title":"Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}