federal_register: 2013-23795

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2013-23795 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 Notice 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. 2013-10-01 2013 10 https://www.federalregister.gov/documents/2013/10/01/2013-23795/investigational-device-exemptions-for-early-feasibility-medical-device-clinical-studies-including https://www.govinfo.gov/content/pkg/FR-2013-10-01/pdf/2013-23795.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...  

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