FDA releases guidance on implanted BCI devices

The FDA released a guidance document on the non-clinical testing and clinical considerations of ‘Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation’. The document can be downloaded from the FDA website.

One point of particular interest comes from the software section, where the FDA states that “We generally consider the software for implanted BCI devices to present a “major” level of concern.” If this is not the case, the manufacturer should provide scientific justification for their rationale. It then goes on to point to several relevant standards that they recommend to be followed when putting together a submission.

 

 

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.