Sponsors of brain implant trials seeking an investigational device exemption may be asked to demonstrate that their devices can work in “realistic home use environments,” the FDA said in a draft guidance.
In general, the FDA doesn’t grant IDEs for brain implants because it considers them significant-risk devices. But the agency may consider granting exemptions to trials of implants aimed at repairing catastrophic spinal damage or lost limbs if sponsors can show in their protocols that their trials approximate “realistic home-use environments.”
The guidance notes that the FDA is not likely to give an IDE to trials involving patients with histories of seizure, intellectual impairment, “clinically relevant memory problems,” psychosis or a chronic psychiatric disorder.
You can read the draft guidance here: www.fdanews.com/02-28-19-Brainimplant.pdf.