{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.\" Through the approaches announced in this guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE regulations. Early feasibility studies allow for limited early clinical evaluations of devices to provide proof of principle and initial clinical safety data, often before the device design is finalized. This guidance addresses the information that should be provided to FDA in support of an early feasibility study IDE application and explains the requirements applicable to modifications to the device design or clinical study protocol during the early feasibility study.","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/2013/10/01/2013-23795.html","cfr_references":[],"citation":"78 FR 60291","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-D-0787"],"dockets":[],"document_number":"2013-23795","effective_on":null,"end_page":60292,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/10/01/2013-23795.xml","html_url":"https://www.federalregister.gov/documents/2013/10/01/2013-23795/investigational-device-exemptions-for-early-feasibility-medical-device-clinical-studies-including","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-23795?publication_date=2013-10-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-10-01/2013-23795/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":754,"last_updated":"2026-06-12 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-10-01/pdf/2013-23795.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-23795.pdf?1380545393","publication_date":"2013-10-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/10/01/2013-23795.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-2011-D-0787","supporting_documents_count":0,"docket_id":"FDA-2011-D-0787","regulation_id_number":null,"title":"Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies; Availability","checked_regulationsdotgov_at":"2013-10-21T06:00:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60291,"subtype":null,"title":"Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, etc.","toc_subject":"Draft Guidance for Industry and Staff; Availability:","topics":[],"type":"Notice","volume":78}