FDA "Does Not Intend to Object" To Unapproved Fever Detection Cameras If No 'Undue Risk'

The US FDA has declared it will not go after the many companies marketing unapproved fever detection cameras during the coronavirus public health emergency as long as they "do not create an undue risk", even though it does consider these products medical devices, it has announced in new guidance.

The guidance comes after weeks of uncertainty about the legal status of these products, which traditionally require FDA 510(k) clearance prior to being marketed/sold. But that has not stopped numerous firms from touting unapproved cameras as they cash in on a pandemic-induced Gold Rush.

However, in order to "help address urgent public health concerns", the FDA is now saying it "does not intend to object" to the distribution of unapproved fever detection cameras, although this leniency will "remain in effect only for the duration of the [COVID-19] public health emergency". Moreover, the FDA is reserving the right to go after products that "craete an undue risk".

In this note, IPVM examines this new announcement and its impacts closely, including:

• Background: FDA Regulation of Fever Screening Cameras
• FDA New Thermal Camera Enforcement Policy Announced
• FDA Reasoning: Fighting Shortage
• Policy Only Temporary
• Fever Cams Still Medical Devices
• Winner Dahua, Loser Hikvision
• Other Winners And Losers
• New Entrants
• Risk of Shoddy Products Spreading

Background: FDA Regulation of Fever Screening Cameras

As IPVM reported last month, the FDA considers body temp screening cams (paired with a thermometer to confirm the fever) to be medical devices, technically a "Telethermographic system intended for adjunctive diagnostic screening". These require FDA 510(k) clearance before being marketed, a process that takes around 130 days.

FDA Announces It Won't Enforce Its Own Regulations

However, the FDA announced new guidance yesterday (April 16) stating it will temporarily "not intend to object" to those selling such cameras without 510(k) clearance:

To help ensure the availability of products that might offer benefit to health care providers and the general public during the public health emergency, FDA does not intend to object to the distribution and use of telethermographic systems intended for initial body temperature assessment for triage use [emphasis added]

The FDA has released a 10-page enforcement policy labeled 'contains nonbinding recommendations':

FDA Reasoning: Fighting Shortage

The FDA said it is doing this as it wants to address the shortage of such devices:

FDA believes the policy set forth in this guidance may help address urgent public health concerns raised by shortages of temperature measurement products by helping to clarify the regulatory landscape and expand the availability of telethermographic systems used for initial body temperature measurements for triage use during this public health emergency. [emphasis added]

Policy Only Temporary

The FDA emphasized that this guidance is temporary:

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by HHS

There is no indication of when HHS will declare COVID-19 to no longer be a public health emergency; yesterday, an-all time high of over 2,400 Americans died from the virus and over 500,000 have tested positive so far.

The last US public health emergency was Swine Flu, which lasted well over a year - it was declared in April 2009 and ended in June 2010. Given COVID-19's greater impact, it will likely last at least as long, if not significantly longer.

Fever Cams Considered Medical Devices

Despite some companies falsely claiming their fever cameras are somehow not medical devices, in this guidance, the FDA clearly states that it does consider these products medical devices and under its regulatory purview:

Telethermographic systems are devices when they are intended for a medical purpose, such as measurement of the self-emanating infrared radiation that reveals the relative temperature variations of the surface of the body

Generally, telethermographic systems fall within the definition of a device when they are intended for a medical purpose

This means that companies selling these systems will still need 510(k) clearance to sell fever detection cameras once the pandemic is over. However, the money for them is likely to be made in the immediate future.

"Undue Risk"

However, the FDA emphasized, in the same guidance, that this only holds "where such devices do not create an undue risk", specifically saying that:

FDA believes devices included in this enforcement policy will not create such an undue risk where the performance and labeling elements in Section IV.D are met and An elevated body temperature measurement is confirmed in the context of use with secondary evaluation methods (e.g., non-contact infrared thermometer (NCIT) or clinical grade contact thermometer). [emphasis added]

FDA Recommendation: Only Use With Thermometer

While the FDA said that 510(k) clearance is temporarily waived, it did state this was as long as the cameras are for "triage use", i.e. the cameras are paired with a body thermometer to confirm whether the person actually has a fever:

An elevated body temperature measurement is confirmed in the context of use with secondary evaluation methods (e.g., non-contact infrared thermometer (NCIT) or clinical grade contact thermometer)

FDA Testing/Labeling Recommendations

The FDA also recommended the fever cams are "tested and labeled consistent with the following ISO standard: IEC 80601-2-59:2017" or any "alternative performance specifications that provide similar results to IEC 80601-2-59:2017".

The FDA recommended thermal cams are tested under following "performance specifications" including "measurement uncertainty, is less than or equal to ±0.5°C (±0.9°F) over the temperature range of at least 34-39°C (93.2-102.2°F)".

FDA Recommends Cameras Only Used One Person at A Time

The FDA recommended:

should be used to measure only one subject’s temperature at a time

The recommendation about only measuring one person's temp at a time goes against some firms, like Sunell's Panda Cam, which touts simultaneous fever detection:

For example, ADI yesterday sent an email saying that WatchNet (Sunell relabeller) can (impossibly) detect 16 people in 1/33 of a second:

WatchNET’s Body Temperature Detection System can detect 16 people’s temperature within 30 milliseconds

Prominent Notice Labelling

The FDA says that a 'prominent notice' should be included, explaining:

The labeling includes a prominent notice that the measurement should not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease;

IPVM has mocked up such a notice:

Long List of Label Recommendations

Moreover, the FDA gave many other label recommendations that should be on the devices in order for users to "better understand the device":

How or where this long list of labeling should be applied is not made clear. We asked the FDA for feedback and will update with their response.

Recommendations Nonbinding

Despite this long list of recommendations, the FDA states it its advice is not enforceable or required:

In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required. [emphasis added]

On the other hand, the 'undue risk' clause opens the regulatory risk that systems not following the performance and labeling requirements could face action.

Risk: Dubious Companies Rewarded

There has been an explosion in firms touting unregulated coronavirus-detection camera solutions. IPVM has counted 49 companies now offering such solutions, of which only a few have 510(k) clearance. Problems included:

• Athena Security faked its coronavirus marketing and is using the wrong kind of camera
• Feevr is also using the wrong kind of camera and when IPVM reported this, they threatened legal action and made false allegations against us
• Dahua also faked its coronavirus marketing

The fact that the FDA has (temporarily) given carte blanche to these unregulated products is a big boost for such firms. But it presents a risk to the public since often these companies are totally new entrants to the thermal field and do not offer the right kind of camera, setup advice, etc. This could lead to many false positives/negatives and poor implementation.

Analysis: Dahua Winner, Hikvision Winner But Less So

Neither Dahua nor Hikvision had FDA clearance for their thermal products going into this crisis. But Dahua decided to aggressively push fever detection anyway, even faking its marketing, while Hikvision took the more cautious path and avoided doing so in the US (it touts these products internationally, though).

But thanks to this new FDA guidance, Dahua's riskier bet is now looking like a huge winner. The thermal camera market has exploded thanks to the pandemic, with end users frantically seeking to protect clients in any way they can, and Dahua now has a big edge.

Approved Lose Somewhat

FLIR, Optotherm, and all the other established manufacturers who make FDA-cleared fever screening cameras have lost a significant selling point for their products: that they are the only government-approved game in town. On the other hand, those companies have significant backlogs in orders so they are still selling out of everything they can make and clearly getting a big boost from this.

Downside: Encouraging Bad Practices

On the downside, the FDA's new guidance will result in even more dubious thermal solutions being touted, and allow the fever cam Gold Rush to accelerate. Poorly-implemented solutions will likely cause false negatives/positives, leading to unnecessary harassment for regular people. Meanwhile, many will rush to buy the cheapest solution or the one with slickest marketing or simply what they can actually find available.

Another major issue is what will happen when the pandemic is over and the FDA once again requires 510(k) clearance for such solutions. Though, many of these systems may be abandoned by that time anytime.

Upside: Clarity Finally Here, More Companies Can Enter

On the plus side, the FDA's new guidance does offer clarity to a previously fraught situation. Many companies were declining to enter the market due to legal risks. Now, they can join which might help expand options.

Poll / Vote