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Guidance Issuing OfficeOffice of Medical Products and Tobacco, Center for Devices and Radiological Health
This draft guidance document provides draft recommendations for Q-Submissions and Investigational Device Exemptions (IDEs) for implanted Brain-Computer Interface (BCI) devices for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 For the purposes of this draft guidance document, implanted BCI devices are neuroprostheses that interfaces with the central or peripheral nervous system to restore lost motor and/or sensory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. FDA considered the input provided during this workshop to develop the recommendations provided in this draft guidance document for implanted BCI devices. This draft guidance is issued for comment purposes only.
This draft guidance document provides non-clinical testing and clinical study design recommendations associated with implanted BCI devices.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 that 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.
The Agency strongly encourages manufacturers to engage with CDRH through the Q-Submission process to obtain more detailed feedback for BCI devices. For more information on Pre-Submissions, please see “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff.”
For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database Web site at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff.”
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2014-N-1130.