美国FDA 指导原则 瘫痪或截肢患者用植入式脑机接口(BCI)设备.工业和食品药品监督管理局工作人员的非临床测试和临床考虑指南 英文原版.pdfVIP

Contains Nonbinding Recommendations Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation- Non-clinical Testing and Clinical Considerations Guidance for IndustryandFood and Drug Administration Staff Document issued onMay 20,2021. The draft of this document was issued onFebruary 22, 2019. For questions about this document, contactthe OHT5: Office of Neurological and Physical Medicine Devices/DHT5B: Division of Neuromodulation and Physical Medicine Devices/Acute Injury Devices Team at (301) 796-6610. U.S.Department of Health and Human Services U.S. FOOD DRUG Food and Drug Administration ADM I N I S T RATI ON Center for Devices and Radiological Health Contains Nonbinding Recommendations Preface Public Comment You may submit electronic comments and suggestions at any time for Agency consideration to.Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket numberFDA-2014-N-1130.Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@to receive a copy of the guidance. Please use the document number 1500045 and complete title of the guidance in the request. Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION1 II. SCOPE2 III. PRE-SUBMISSION IDERECOMMENDATIONS3 A. DEVICEDESCRIPTION3