The FDA has issued newly-finalized guidance to help manufacturers of knee-replacement products properly apply for investigational device exemptions.
The document also offers similar steering for makers of drugs, biologics and hybrid products related to knee treatments, said FDA in its Jan. 18 announcement of the guidance in the Federal Register. The guidance does not apply to manufacturers of prostheses, total knee implants or meniscus replacement products.
The document, “Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage,” is the final draft of a document dating to July 2007. It includes responses to comments submitted by manufacturers and other stakeholders during the draft process.
To download the document as a PDF, click here.