Device Classification Stand Off With Software Developer Warrants Warning

The FDA has escalated a long-simmering dispute with Israeli-owned software developer NeuroTrax about the proper classification for its MindStreams cognitive health assessment tool, telling the company in a warning letter it must seek Class III status or halt marketing the product. NeuroTrax is marketing its MindStreams software without marketing clearance or approval by the FDA, which has determined the product to be a Class III device posing heightened risk to patients, the agency said in a March 15 warning letter posted April 3. The company also lacks an approved application for an investigational device exemption for the product, the letter states.
The GMP Letter