Life Sciences

FDA offers advice on how to submit IDEs for artificial discs

Device Regulation Alert: Safety, Compliance and Reimbursement News, May 12, 2008

New guidance assists the device industry with investigational device exemption (IDE) applications for total artificial disc devices. The guidance only applies to total interverterbral disc replacement systems, not to other spinal systems that allow some spine motion, such as spinal stabilization systems that use flexible implants without fusion, partial intervertebral disc replacements, and spinal joint replacements. For those types of complex devices, sponsors should submit pre-IDE submissions to the Orthopedic Spine Devices Branch (OSDB).
           
The guidance for total artificial discs addresses what pre-clinical tests should be conducted and how clinical trials should be set up to ensure the effectiveness and safety of the devices. The guidance provides recommendations that should be added to those supplied in the more general “Guidance Document for the Preparation of IDEs for Spinal Systems.” In fact, throughout the guidance the FDA refers to that spinal system guidance for additional detail on issues such as labeling of the device, clinical investigation plans and monitoring procedures.
 
 

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