Dear FDA: Why Eagle Eye Needs To Be Punished

IPVM has sent a letter to FDA Commissioner Janet Woodcock, and Jeffrey E. Shuren, Director of the Center for Devices and Radiological Health after (1) Eagle Eye ran an FDA-Violating marketing campaign and then (2), last week, expanded the campaign sending it to thousands of schools via a Campus Safety newsletter promotion.

Dear Dr. Woodcock and Dr. Shuren:

Texas-based Eagle Eye Networks' thermal temperature screening products are creating undue risk to public health, due to the company's continued flagrant violation of FDA guidelines in marketing and deployments at various US schools.

In June 2021, Eagle Eye published a 'success story' for an Alabama school district deployed at 11 locations in response to the 'COVID-19 pandemic' [their words]. Eagle Eye emphasized that their devices needed to follow the FDA's "extremely strict usage guidelines".

On August 5, 2021, our organization, IPVM, published a report titled "FDA-Violating Eagle Eye Fever Screening Endangers Schools" explaining how Eagle Eye's deployment and marketing violated FDA guidelines including multi-person, non-climate controlled, windowed and obstructed covering screening, as this video summarizes:

We informed Eagle Eye of these concerns 6 days prior to publishing. Eagle Eye declined to comment and continued to market this material.

On August 19, 2021, Eagle Eye ran a newsletter marketing campaign with Campus Safety magazine promoting the same Alabama schools temperature screening, screencap of this marketing:

Campus Safety has 30,000+ emails on its product newsletter with 2/3rds of them from School District/K-12 or College/University, per the company's 2021 media kit.

We contacted Eagle Eye about this newsletter campaign and again the company refused to comment.

This is an especially egregious case that the FDA should take action on, for 6 reasons:

1. This is based on an actual, active deployment in which real American lives are at risk. Eagle Eye leveraged violating usage for its violating marketing.
2. In their marketing, Eagle Eye emphasized how important it was to follow FDA's "extremely strict usage guidelines". They cannot argue they did not know the guidelines existed nor their importance.
3. When we reported on this and shared our concerns, not only did Eagle Eye refuse to comment, they refused to withdraw the marketing.
4. Now, they have gone to one of the largest school publications advertising what they know to be an FDA violation, to ~20,000 school email addresses.
5. Moreover, Eagle Eye's supplier, Sunell, was already issued an FDA warning letter, 5 months ago. This was public information reported in the Washington Post and other outlets.
6. The Eagle Eye case study admitted they averaged nearly 500 "temperature notifications per month" and that the school reached a "level of frustration at the volume of false positives" while deploying an FDA-violating system.

Eagle Eye’s deployment creates exactly the kind of “undue risk” that FDA’s April 2020 enforcement policy defined as cause for action. Furthermore, FDA publicly warned in March 2021 that “potentially serious public health risks…are more likely to be present where thermal imaging systems scan multiple individuals simultaneously" exactly what Eagle Eye's marketing and deployments do.

Eagle Eye shows no signs of stopping unless the FDA intervenes. It has ignored private and public scrutiny about its FDA violations. It knows its supplier was already warned by the FDA. It knows its deployments and marketing violate FDA guidelines.