Thermal Imaging Devices: Deregulated by FDA Leave a comment

In the United States. the Food and Drug Administration (FDA) regulates all medical devices, including thermal imaging devices. When a manufacturer wants to sell a medical device, they must be approved by 1 of 2 methods:

• 510k clearance: manufacturers must notify the FDA of their intent to market a medical device 90 days in advance. They must also prove that the product is safe and effective.
• Pre-market approval: more in-depth than 510k. The device must prove that it is safe and effective through detailed clinical trials and reports using human participants.

Thermal imaging devices are usually counted as a medical device if they are used to diagnose illnesses. However, more people are buying thermal cameras as a way to screen for fevers, a common symptom of COVID-19. In response to shortages of these temperature measurement products, the FDA has temporarily lifted their requirements. They state that thermal devices that were originally for construction and industrial uses can be repurposed to help screen for high body temperatures in high traffic areas.

Exemption Guidelines

However, these exemptions only apply to thermal imaging systems that are going to be used for non-medical purposes. If a thermal camera is marketed to detect fevers or COVID-19 on its own, it will require pre-market approval. Thermal devices that will be used as an “adjunctive” tool, meaning it’s used in conjunction with a body thermometer that confirms the fever, are subject to 510k clearance but not pre-market approval. In other words, thermal cameras can be used as a way to measure temperature, but can’t be used to actually confirm if a person does have a fever or COVID-19.

Marketing Intent

Although the FDA won’t be actively regulating non-medical thermal imaging devices, they suggest manufacturers to add labels to their products to avoid confusion in the consumer market. They recommend labels stating that the device should not be “primarily relied upon to diagnose or exclude a diagnosis of COVID-19”. The labels should also note that high body temperatures should be confirmed with a secondary evaluation method like a clinical grade thermometer.

But simply labeling a thermal imaging device as not being intended for medical use is not acceptable. If the thermal device is being marketed as a way to detect illness then its intended use is medical and is subject to approval. It’s important to avoid legal issues when marketing these devices by thinking about how you want the end user to use the product.

The FDA is attempting to slow down the spread of the virus by allowing more thermal cameras in the market, but there are still guidelines to follow. Thermal devices are good for detecting high body temperatures which may indicate a fever, but they should not be relied on to diagnose fevers and COVID-19. Always take other precautions such as wearing a mask and social distancing.

As always, don’t hesitate to contact us if you have any more questions. You can call us at 877-926-2288 or connect with us on social media
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