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 investigation new drug applications.
The new guidance is the finalized form of a draft in the works since July 2007, and includes sections detailing clinical study schedules and non-clinical data considerations in response to comments the agency received during the draft process.
Required documents for IDEs include written descriptions of individual components, materials, anticipated changes to the device and evidence that instrument materials are safe for limited contact with a breached surface.
The agency also modified some of the language in the original document to be more consistent with ...
