Makers of neuroprostheses navigate regulatory process
DOI: 10.1063/PT.5.028458
Nature : Rapid advances are being made in the field of brain–computer interface devices that connect with the central nervous system to restore motor control in patients with paralysis or amputation. Devices range from implants in the brain to electrodes and sensors placed on the scalp. The implants are the riskiest because they require surgery and it’s not known how long the electrodes can safely remain in the brain. As such devices will soon reach the point of being commercially viable, manufacturers are also working to ensure that they meet the safety regulations of the US Food and Drug Administration and to persuade health insurers to pay for them. The FDA recently held a workshop in Silver Spring, Maryland, to discuss and obtain public feedback on just such issues.
