{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Implanted Brain- Computer Interface (BCI) Devices for Patients with Paralysis or Amputation--Non-Clinical Testing and Clinical Considerations.'' Implanted brain-computer interface (BCI) devices are neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation. This guidance provides recommendations for nonclinical testing and study design considerations for investigational device exemptions feasibility and pivotal clinical studies.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2021/05/20/2021-10622.html","cfr_references":[],"citation":"86 FR 27443","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 20, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1130"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2021-05-20","updated_at":"2025-07-18T10:56:50.922-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-N-1130-0018","allow_late_comments":false,"id":"FDA-2014-N-1130-0018","comment_end_date":"2019-04-27","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2014-N-1130","title":"Brain-Computer Interface Devices for Patients with Paralysis and Amputation; Public Workshop; Request for Comments"}],"document_number":"2021-10622","effective_on":null,"end_page":27444,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/05/20/2021-10622.xml","html_url":"https://www.federalregister.gov/documents/2021/05/20/2021-10622/implanted-brain-computer-interface-devices-for-patients-with-paralysis-or-amputation-non-clinical","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-10622?publication_date=2021-05-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-05-20/2021-10622/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1005,"last_updated":"2026-04-18 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-20/pdf/2021-10622.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-10622.pdf?1621428330","publication_date":"2021-05-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/05/20/2021-10622.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-1130","supporting_documents_count":0,"docket_id":"FDA-2014-N-1130","document_id":"FDA-2014-N-1130-0018","regulation_id_number":null,"title":"Brain-Computer Interface Devices for Patients with Paralysis and Amputation; Public Workshop; Request for Comments","checked_regulationsdotgov_at":"2025-07-19T17:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27443,"subtype":null,"title":"Implanted Brain-Computer Interface Devices for Patients With Paralysis or Amputation-Non-Clinical Testing and Clinical Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Implanted Brain-Computer Interface Devices for Patients with Paralysis or AmputationNon-Clinical Testing and Clinical Considerations","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":86}