{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.'' FDA has developed this document to describe relevant information that should be included in test report summaries, test protocols, and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests).","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/2019/04/26/2019-08466.html","cfr_references":[],"citation":"84 FR 17838","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on April 26, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-1329"],"dockets":[],"document_number":"2019-08466","effective_on":null,"end_page":17840,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/04/26/2019-08466.xml","html_url":"https://www.federalregister.gov/documents/2019/04/26/2019-08466/recommended-content-and-format-of-non-clinical-bench-performance-testing-information-in-premarket","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-08466?publication_date=2019-04-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-04-26/2019-08466/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":867,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-04-26/pdf/2019-08466.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-08466.pdf?1556196338","publication_date":"2019-04-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/04/26/2019-08466.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-D-1329","supporting_documents_count":0,"docket_id":"FDA-2018-D-1329","regulation_id_number":null,"title":"Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff","checked_regulationsdotgov_at":"2019-05-16T10:00:31Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":17838,"subtype":null,"title":"Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":84}