Draft Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Intended to Repair or Replace Knee Cartilage; Availability

摘要

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 The draft guidance provides to sponsors recommendations about certain information that should be included in an investigational device exemption (IDE) or investigational new drug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 The draft guidance, when finalized, will supplement other FDA publications on IDEs and INDs.