DOPATREE US CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) US FDA CDRH / RELATED MEDICAL DEVICES-ALL (ALL MEDICAL DEVICES, 513G, 513(G), MULTIPLE DEVICES, SINGLE FUNCTION, EQUIPMENT, CLASS I, II, III, 515(B), 515B, MANUFACTURERS, GENERAL) MEDICAL DEVICES / LISTINGS NEUROLOGICAL MEDICAL DEVICES-ALL (PSYCHIATRIC MEDICAL DEVICES) NEUROLOGICAL MEDICAL DEVICES / LISTINGS BRAIN-COMPUTER INTERFACE DEVICE (BCI, NEURAL-CONTROL INTERFACE, NCI, MIND-MACHINE INTERFACE, MMI, DIRECT NEURAL INTERFACE, DNI, BRAIN-MACHINE INTERFACE (BMI) BCI DEVICE / LAWS AND REGULATIONS / US US FDA. GUIDANCE. IMPLANTED BRAIN-COMPUTER INTERFACE (BCI) DEVICES FOR PATIENTS WITH PARALYSIS OR AMPUTATION - NON-CLINICAL TESTING AND CLINICAL CONSIDERATIONS. MAY 20, 2021.