Implanted brain-computer interface (BCI) devices for patients with paralysis or amputation: non-clinical testing and clinical considerations : guidance for industry and Food and Drug Administration staff

Implanted brain-computer interface (BCI) devices for patients with paralysis or amputation: non-clinical testing and clinical considerations : guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Language(s):
English
Format:
Text
Subject(s):
Amputation, Surgical
Brain-Computer Interfaces
Equipment Design
Equipment Safety
Paralysis
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance document provides recommendations for Q-Submissions and Investigational Device Exemptions (IDEs) for implanted Brain-Computer Interface (BCI) devices for patients with paralysis or amputation. The field of implanted BCI devices is progressing rapidly from fundamental neuroscience discoveries to translational applications and market access. Implanted BCI devices have the potential to bring benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life. For the purposes of this guidance document, implanted 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. FDA’s Center for Devices and Radiological Health (CDRH) believes it is important to help stakeholders (e.g., manufacturers, health-care professionals, patients, patient advocates, academia, and other government agencies) navigate the regulatory landscape for medical devices. Towards this goal, on November 21, 2014, CDRH held an open public workshop on its White Oak, MD campus with the aim of fostering an open discussion on the scientific and clinical considerations associated with the development of BCI devices.1 FDA considered the input provided during this workshop to develop the recommendations provided in this guidance document for implanted BCI devices. This guidance document provides non-clinical testing and clinical study design recommendations associated with implanted BCI devices. Non-clinical device testing can be used to demonstrate hat potential risks have been mitigated prior to initiating a clinical study. Proper design of clinical trials is essential to provide a reasonable assurance of safety and effectiveness necessary to support a regulatory submission, and translation of BCI devices from concept to assisting device users. This guidance is a leapfrog guidance, a type of guidance that serves as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development. This leapfrog guidance represents the Agency’s initial thinking and our recommendations may change as more information becomes available.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (41 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918350986806676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918350986806676