Warning Letter: FDA Allege Wavi is Selling Unapproved Neurological Device

Wavi, a neurological medtech company, was recently hit with a warning letter from FDA accusing the company of selling an unauthorized device to help diagnose patients with potential neurological conditions. The company promotes and distributes Wavi Desktop, a product that collects, analyses, and interprets electroencephalograph data, event-related potentials, and heart rate variability data.

“Labeling in your Wavi Instruction Manual provided to customers contains, but not limited to, evidence that the device is intended to aid in the evaluation of autonomic nervous system function, head injury, depression, attention-deficit/hyperactivity disorder (ADHD), anxiety, and cognitive function,” FDA wrote in the letter.

FDA sent inspectors to the company’s facility in Denver, CO, in March, and decided that the technology was categorized as a medical device needing premarket approval: something Wavi has not obtained. In response, the company told FDA that the product was for research purposes only and did not need such approval. However, according to FDA, the company didn’t provide evidence of an approved investigational device exemption (IDE) application. Again, Wavi responded by stating the studies to build Wavi Scan were IDE exempt and that Wavi Desktop was not subject to IDE requirements. The letter the company sent to FDA, according to the warning letter, lacked supporting evidence of such exemptions.

FDA also rebuked Wavi’s claim that the device was only used in research settings, quoting the company’s website which said the device provides “doctors, researchers, and wellness experts with actionable, data-driven reports,” as well as multiple physician testimonies. The website, according to the warning letter, also previously allowed users to search for practitioners that made clinical use of the device.

“Specifically, during the inspection, you provided a list of recent publications and studies accompanied by a list of recent academic partners. However, your list of customers that was collected by our investigator is far more extensive than these academic partners,” FDA wrote.

The warning letter also highlighted alleged violations of quality system regulations, including the distribution of devices with non-validated Wavi Desktop research software. The administration said that the company failed to perform validation of device software, failed to validate the test fixture of the device’s electrical processing unit, to maintain device history record and master device records, and to create and establish quality adults. Wavi responded to the claim by stating “there is no requirement for research software to be validated.” FDA disagreed.

Wavi is now charged with resolving the violations or be subject to additional penalties.