FDA Gives Guidance on 'Coronavirus' Thermal Fever Detection Systems
The US FDA has given IPVM guidance on the use of thermal fever detection systems being marketed for coronavirus, as an explosion of such devices has occurred in the past month.
While some companies are marketing these as a coronavirus solution, such activity is potentially illegal in the USA without some form of FDA clearance or approval.
In this post, we explain what equipment is concerned, what levels of approval is required, current solutions available, and more, including:
- Are Thermal Cameras Medical Devices?
- 510k Clearance Vs Premarket Approval
- FDA Official Explains When Clearance/Approval Required
- FDA Caveat: Can't Comment on Specific Products
- Easy To Find FDA Cleared/Approved Devices
- Be Wary Of "Coronavirus Detection" Solutions
- Update: "Not A Medical Device" Disclaimers Don't Work
Are Thermal 'Fever' Cameras Medical Devices?
The answer is generally yes if the cameras are being used to help diagnose illnesses such as a fever. This is important since the FDA regulates medical devices, including "telethermographic" (thermal) cameras. The CDC has a list of "FDA-regulated devices for measuring temperature" that includes "telethermographic system (“thermal scanners”)".
510k Clearance Vs Pre-market Approval
These are two main ways the FDA greenlights medical devices:
- 510k clearance is for less risky devices and is based on a company submitting documents to the FDA showing that its product is "Substantially Equivalent" to devices legally marketed in the US prior to 1976. As of Q3 2018, this process takes about 130 days.
- Pre-market Approval (PMA) is the "most stringent" process and requires submitting detailed (and expensive) lab and clinical studies. As of Q3 2018, this takes about 265 days, or twice as long.
FDA Official Explains When Clearance/Approval Required
An FDA official told IPVM that if a thermal camera is being used as an "adjunctive" tool - meaning it is paired with a body thermometer that actually confirms the fever - it requires 510k clearance:
when this device is not the sole diagnostic screening tool, such as if it is being used in conjunction with a legally-marketed thermometer, the device may be used without the requirement of pre-market approval [...] Product code LHQ, telethermographic systems for adjunctive use, require a cleared 510(k) to be legally marketed.
This is important to note since some firms, like Athena Security, are recommending using their uncleared device with an FDA-approved thermometer is used:
Sole Purpose Camera Requires Pre-Market Approval
The FDA also said that if a company were to market a thermal camera that could detect fever or coronavirus entirely on its own, then it would require Pre-Market Approval. However, the FDA has not granted any approval to a thermal camera that can, by itself, diagnose illness.
FDA Caveat: Can't Comment on Specific Products
To be clear, the FDA cannot tell IPVM whether a specific solution is legal or illegal since the coronavirus solutions that have recently exploded onto the scene have not been classified by the FDA and determined to be medical devices. The official explained:
In making a determination, the FDA requests detailed information about the device, including intended use, physical description and mechanism of action, and any claim they intend to make about the product. This generally is a significant legal decision that cannot be made based on a description on a company’s website or information provided by the media.
IPVM has formally notified the FDA of both Athena Security and Dahua USA marketing thermal cameras as a coronavirus solution and we will update if they decide to investigate.
Easy To Find FDA Cleared/Approved Devices
It's easy to find cameras that have received 510k clearance by the FDA (for adjunctive purposes) by looking up the correct product code (LHQ) on the FDA's website. A number of offerings used at places like airports, such as FLIR, ICI, and Optotherm are listed.
Be Wary Of "Coronavirus Detection" Solutions
End users and integrators should be wary of solutions that claim to detect fever or coronavirus, since this is not what thermal cameras can do; even the best thermal cameras can only find higher body temperatures, potentially missing asymptomatic people or those with a low fever. FLIR itself explicitly states:
Can thermal cameras be used to detect a virus or an infection? The quick answer to this question is no, but thermal imaging cameras can be used to detect Elevated Body Temperature.
There is a legal risk to marketing thermal cameras to find coronavirus (or other illness) as a camera that could actually do this would require pre-market approval. For example, in 2016, the FDA sent a letter of warning to a firm that was touting FLIR cameras for breast cancer screening for "marketing these IR cameras with a major change or modification in intended use". A similar case happened again in 2019.
Breaking FDA regulations can result in anything from warning letters to seizures, fines of up to $500,000, and criminal prosecution.
FDA Evaluating Accelerated Response To Pandemic
Finally, the FDA told IPVM that they are examining ways to accelerate allowing more devices to be used to help in response to the pandemic:
We are aware of potential challenges for those wishing to obtain temperature screenings. The FDA is committed to maximum regulatory flexibility in its response to this pandemic, while assuring products are appropriate for use. The FDA has a variety of tools to help meet the medical device needs of the American people during a public health emergency, including the ability to authorize emergency use of an unapproved medical device or product marketed for medical purposes that is eligible for such use, in certain circumstances. We are evaluating the best approach to help to ensure the availability of critical and appropriate medical devices.
Update: 'Not A Medical Device' Disclaimers Not Valid
Some companies worried about FDA regulation are selling thermal cameras with disclaimers stating 'this is not a medical device and not meant to diagnose disease'. However, it doesn't matter if the company says 'this is not a medical device', what matters is the intended use of the product.
The FDA states that a medical device is a product "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals" [emphasis added]. If the cameras are intended to be used to screen fevers, then the intended use is clearly medical.
Bradley Merrill Thompson, an attorney and consultant focused on FDA regulation of medical devices, told IPVM:
A product becomes a medical device based on the objective intent of the manufacturer/seller with regard to how it intends purchasers to use the product, as gleaned from the evidence with regard to how it is designed and marketed
Due to the coronavirus, many are scrambling for a quick fix. However, even in times of crisis, it is worth keeping in mind the legal requirements for health-related solutions.
IPVM recommends integrators and end users carefully evaluate the legal risks of the solutions they offer and ask that the manufacturers of these solutions to ensure, in writing, the legality of the products they are selling.