From a biocompatibility perspective neurological devices are primarily implants, though some devices such as topical stimulators are less critical. Neurological devices often utilize standard polymeric materials or metal alloys as well as biological substances. This device category includes neurostimulators, nerve regeneration materials, dura mater and brain contact materials, and bone repair or fixation products. In this latter case, there is overlap with orthopedic device requirements.
The following information applies primarily to hard implant devices having exposure to brain, dura mater, spinal cord and fluid and peripheral nerves. Please also see our information on Orthopedic Implant Devices and Bone Cement. NAMSA Technical Specialists and Scientists are adept at developing non-clinical programs for these products. Veterinary surgeons on staff are experienced at implanting and/or evaluating the biocompatibility and functionality of such devices.
While some neurological devices may be short-term or "externally communicating," the majority are long-term implants. Depending upon the exact nature of the materials in the neurologic device, testing concerns can be significant.
Standards and Regulation
First consideration should be given to any FDA guidelines available or to any ISO vertical standard in use for a specific device. In the absence of such guidance, ISO 10993 should be consulted to determine potential areas of concern.
Each device should be examined on its own merits. In some cases, prior data may be available from suppliers or in the literature, or there may be efficacy or functionality testing in progress that can be used to satisfy some of the safety requirements.
