FDA WARNING_LETTER - SyncThink, Inc.

The FDA issued a Warning Letter to SyncThink, Inc. regarding their EYE-SYNC device (CMS #498523). The FDA determined that SyncThink is marketing the EYE-SYNC device in the U.S. without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The EYE-SYNC device is deemed adulterated under section 501(f)(1)(B) of the Act because SyncThink lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act because SyncThink introduced the device into interstate commerce with major changes to its intended use without submitting a new premarket notification (510(k)).

Specifically, the device was cleared under K152915 for recording, viewing, and analyzing eye movements to identify visual tracking impairment. However, SyncThink's website promotes the device for cognitive assessment/testing of concussions and head trauma in athletes and soldiers, which constitutes a major change in intended use requiring new clearance or approval. Examples from their website include "advanced cognitive assessment," "initial screening and recovery monitoring" for concussions, and "assessing return to play or work."

The FDA requests SyncThink immediately cease activities resulting in the misbranding or adulteration of the EYE-SYNC device, such as commercial distribution for the unapproved uses. SyncThink must respond in