FDA Gives Guidance on 'Coronavirus' Thermal Fever Detection Systems

By: Charles Rollet, Published on Mar 30, 2020

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.

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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

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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:

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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

Conclusion

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.

13 reports cite this report:

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Dahua Faked Coronavirus Camera Marketing on Apr 01, 2020
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USA's Seek Scan Thermal Temperature System Examined on Apr 01, 2020
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Terrible Convergint Coronavirus Thermal Camera Recommendation on Apr 01, 2020
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Comments (18)

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If I summarize this correctly, any company promoting a thermal camera for fever screening should be able to produce a 510k cert, or proof of submission for one? And, if they cannot provide such a certification, then the device would be not be able to be advertised for use in fever detection?

They should be able to provide a proper 510k cert (not just proof of submission) since 510k is "premarket notification" - it's a process that should be done before a firm markets the product. And they should also not claim the camera can do fever screening, as shown by FLIR, these cameras can only detect elevated body temps, not fevers per se.

And, if they cannot provide such a certification, then the device would be not be able to be advertised for use in fever detection?

The company can do what it likes but without the FDA cert, yes, it risks potentially being investigated for marketing a device without a 510k.

risks potentially being investigated for marketing a device without a 510k.

Charles, does the FDA or US government explain what is the penalty for marketing a device without a 510k?

saw this, from 2015 though

Penalties

What can FDA do?

Civil monetary penalties (CMPs) have a maximum penalty of $15,000 per violation, not to exceed $1 million for all violations in a single proceeding.

FDA can issue prior warnings before more serious enforcement.

Prior warnings can include:

  • FDA warning letter
  • FDA civil suit, administrative action, or other regulatory correspondence
  • Notification by other state, municipal, or federal agencies involving the same or similar violations
  • FDA-483 (list of inspectional observations) provided by an FDA investigator at the conclusion of an inspection
  • Discussion of objectionable conditions by FDA investigator with firm, as documented in the 483
  • Verbal notification from FDA to top management
  • Written or oral advisory communication by FDA
  • Industry meetings during which FDA discusses violations, if firm’s attendance is documented

There is no specific punishment for marketing without a 510k, I think the most likely outcome would be a letter of warning from the FDA to the company doing it. This is what we've seen in the past:

The letters of warning require the firm to take down their marketing and send a detailed response to the FDA within 15 days.

I couldn't find an example of a firm that ignored the warning letter and kept marketing their device. Firms probably realize complying with the letter is much easier than keeping up their behavior.

I couldn't find an example of a firm that ignored the warning letter and kept marketing their device.

Company Ignores FDA’s Request to Cease Commercial Distribution

Thanks. So in this instance, the FDA told a firm to "immediately cease activities" after it didn't get a 510(k) for a device despite prior instruction to do so. Shows they keep tabs on these companies.

I have spoken with a company that received a warning letter for marketing a thermal camera and software for fever screening in the past. And it was certainly not just a "slap on the hand".

With the warning letter, the FDA will most likely show up unannounced and perform an company audit. A very unpleasant one to say the least. Then, they provide you with a "Corrective Actions" order.

In the example that I mentioned above, the company was asked to recall all cameras/systems sold. The corrective actions measures took 2 years to implement and almost drove that company out of business. The person I spoke with described this as the worst thing that ever happened to their business.

So, if companies think, the worst case will be a little "slap on the hands", they'll be in for a very rude awakening IMHO.

The FDA looks at this from a worst case scenario. What if you install a thermal camera for screening and due to false negatives, an infected person slips through and infects several co-workers. As a result one coworker dies.

All the while everybody felt "safe", because they had a thermal camera installed that was supposed to detect that person.

This opens up the door for a civil law suit in addition to the "slap on the hand" from the FDA.

FLIR does not claim fever screening, they call it "elevated body temperature". Is that a legally sound distinction? I believe the difference between calling the intended use "elevated body temperature screening" vs "fever detection" is whether this is being looked at a diagnostic device or not. Hence, the difference between needing a 510k vs a PMA - Pre-market approval. I am no expert, but that is how I would interpret this.

And even if the camera were to be used for detecting people with an elevated body temperature, it still requires the camera to be used only as an adjunct screening device. In other words, in conjunction with an approved fever thermometer in the hands of a medical professional.

What most integrators overlook as well is, that even if a camera has a 510k, adding software to the [510k approved] camera would require a new 510k application that now incorporates the software. That is because the software is not included in the original filing of the 510k of the camera and does not qualify for the "substantially equivalent" ruling.

Just my 2 cents.

Short answer "The FDA is committed to maximum regulatory flexibility in its response to this pandemic." E.g. Worst case is you get a slap on the wrist right now.

If the statement is correct "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."

These systems are not detecting on their own and the marketing materials need to assert that this is a tool to assist in the process of screening, in most cases that I have heard a screened person with a fever could then be pulled aside for additional testing.

Also, this has to be much safer than having a security guard at the entrance manually taking everyones temperature. If a company is going to deploy temp testing they need help to streamline the process.

Evan, thanks for your comment. We noted in the post that even a camera that is being used in an assistive manner still requires FDA clearance in the form of 510(k) premarket notification.

The issue in video surveillance is that some companies have implied that as long as the camera isn't the sole diagnostic tool, it doesn't need any FDA clearance, which is not true. Fortunately, it is easy to find on the FDA website all the thermal cameras cleared for assistive use.

Finally you noted:

If the statement is correct "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."

This is info we got directly from the FDA, so it is correct. What the FDA are saying is that a camera touted as a sole diagnostic tool would require a much more stringent level of FDA clearance known as Pre-Market Approval.

Hi I think that the the link in the sentence The CDC has a list of "FDA-regulated devices for measuring temperature" that includes "telethermographic system (“thermal scanners”)".

does not connect to the CDC site

Hi, the link works for me - it should direct to a PDF document from the CDC. If you still can't see it, email me (charles@ipvm.com) and I'll send it to you directly.

Any one knows if is necessary any kind of certification on Europe to use thermal câmeras as a human temperature control device? Or if exist any standart?

Hi Carlos, good question. The short answer is no, there's no European certification or standard for body temperature cameras.

The longer answer: The EU was supposed to implement its Medical Device Regulation this May, but it has been delayed for one year, so there's no EU-level requirements/certifications necessary (yet).

Meanwhile, the EU's current Medical Devices Directive hasn't been interpreted by EU countries' FDA equivalent agencies to apply to thermal cameras. I've checked major European nations and haven't found any that classify thermal cameras as medical devices.

My question is related to the concern with what is happening in the European market. Some manufacturers say that the precision should be 0.3º, others say that it should be 0.5º. The information provided by these manufacturers is not supported and could create situations of false security. What is your opinion on the use of these devices for the most correct temperature detection

Most of the systems IPVM has looked at claim accuracy of ±0.3°C or lower, but we are skeptical of such high accuracy under real-world, non-ideal conditions. As we reported before:

Accuracy claims are difficult to assess as some manufacturers are conservative and others almost certainly lying. For example, FLIR states that thermal cameras typically have accuracy +/- 2ºC, but that "with proper calibration and attention to factors such as ambient temperature, emissivity, and spot size, the possible margin of error can be less than 1ºC." Other manufacturers, particularly in China, have claimed up to 0.1°C accuracy, though, of course, whether they are accurate in their accuracy claims should be treated with skepticism.

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