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Medical Devices / Regulatory Affairs

Brain Implant Trials May Need to Include Home Use

March 18, 2019

Sponsors of brain implant trials seeking an investigational device exemption (IDE) may be asked to demonstrate that their devices can work in “realistic home use environments,” the FDA said in a new draft guidance.

The FDA said it generally does not grant IDEs for brain implants because it believes the devices carry significant risks to patients.

However, 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.”

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