{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.\" FDA has developed this document to describe relevant information that should be included in 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 classification requests). This draft guidance is not final nor is it in effect at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2018/05/31/2018-11603.html","cfr_references":[],"citation":"83 FR 25014","comment_url":null,"comments_close_on":"2018-07-30","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by July 30, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-1329"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":20,"comment_start_date":"2018-05-31","updated_at":"2023-03-01T01:40:27.325-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-1329-0001","allow_late_comments":null,"id":"FDA-2018-D-1329-0001","comment_end_date":"2018-07-31","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-1329","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"}],"document_number":"2018-11603","effective_on":null,"end_page":25015,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/05/31/2018-11603.xml","html_url":"https://www.federalregister.gov/documents/2018/05/31/2018-11603/recommended-content-and-format-of-complete-test-reports-for-non-clinical-bench-performance-testing","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-11603?publication_date=2018-05-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-05-31/2018-11603/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1409,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-05-31/pdf/2018-11603.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-11603.pdf?1527684319","publication_date":"2018-05-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/05/31/2018-11603.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":20,"agency_id":"FDA","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","document_id":"FDA-2018-D-1329-0001","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":"2023-03-01T06:40:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":25014,"subtype":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; Availability","toc_doc":"Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}