{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled \"Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage\" dated July 2007. The draft guidance provides to sponsors recommendations about certain information that should be included in an investigational device exemption (IDE) or investigational new drug application (IND) for a product intended to repair or replace knee cartilage. The draft guidance, when finalized, will supplement other FDA publications on IDEs and INDs.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2007/07/09/E7-13162.html","cfr_references":[],"citation":"72 FR 37245","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on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 9, 2007.","disposition_notes":null,"docket_ids":["Docket No. 2007D-0249"],"dockets":[],"document_number":"E7-13162","effective_on":null,"end_page":37246,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2007/07/09/E7-13162.xml","html_url":"https://www.federalregister.gov/documents/2007/07/09/E7-13162/draft-guidance-for-industry-preparation-of-investigational-device-exemptions-and-investigational-new","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E7-13162?publication_date=2007-07-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2007-07-09/E7-13162/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":33,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2007-07-09/pdf/E7-13162.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2007-07-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2007/07/09/E7-13162.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T22:13:19Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":37245,"subtype":null,"title":"Draft Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Intended to Repair or Replace Knee Cartilage; Availability","toc_doc":"Knee cartilage, repair or replacement products; investigational device exemptions and new drug applications; preparation","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":72}