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 document entitled "Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage" dated December 2011. The guidance document provides sponsors of an investigational device exemption application (IDE) or an investigational new drug application (IND) recommendations about certain information that should be included in a submission describing a product intended to repair or replace knee cartilage. The guidance does not apply to prostheses such as unicondylar or total knee implants, or meniscus replacement products. The guidance supplements recommendations regarding IDE and IND submissions contained in other FDA publications. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2007.