A draft guidance document released by the FDA outlines information that should be included when submitting regulatory submissions on patient-matched orthopedic implant guides.
The draft guidance also includes design recommendations for manufacturers of devices.
“This guidance is intended to promote clarity and transparency as to expectations regarding submission recommendations for orthopedic patient-matched guides,” members of the FDA wrote in the draft guidance.
The FDA guidance includes suggestions on the device description, indications for use and software.
