FDA issues guidance on IDEs for knee cartilage repair/replacement devices and drugs (MassDevice)
The FDA issues new guidance on proper submissions for investigational device exemption and investigational new drug applications for products intended to repair or replace knee cartilage.
The FDA this week issued new guidance on getting clearance for clinical trials of products intended to repair or replace knee cartilage.
The guidance covers devices, biologics and hybrid products, outlining required items to include in submission documents for investigation device exemption or ...
