Fever Cameras Are Medical Devices, Per The FDA, Dahua, Feevr, Hikvision, InVid Contrary Claims Are FalseBy Charles Rollet, Published May 28, 2020, 09:12am EDT
Fever cameras are medical devices, despite what euphemisms various sellers use.
The US FDA clearly categorizes them as medical devices and buyers should be warned that claims by Dahua, Feevr, Hikvision, InVid Tech, etc., to the contrary, are false.
Per the FDA, these medical devices work effectively only when they are properly and precisely set up and operated, which many companies are largely ignoring, raising health risks to the public.
Dahua's wiki included the disclaimer that their product "is not a medical device" and is "not designed" to diagnose, prevent, or treat "any disease or condition".
This disclaimer was also featured in an April 2 Dahua/ADI webinar. [UPDATE June 1, 2020: Dahua had ADI remove the webinar, emphasizing their commitment to follow FDA guidance. Below is the clip we saved for historical context:]
Ironically, this is directly contradicted by the description for the webinar, which states these products are meant to help in "reducing the spread of viral diseases":
After IPVM reached out to Dahua about this, they updated their wiki, replacing the "not a medical device" claim with a new disclaimer. Dahua also told us they "updated [their] marketing materials with the new disclaimer in April" (after the webinar came out.)
X.Labs' Feevr includes a 'not a medical device' statement on their disclaimer page, again ironic given the very name of the offering (a play on the word "fever"):
X.Labs did not respond to our request for comment.
A Hikvision brochure for fever cams also says their products "are not medical devices" and cannot be used for prevention of disease:
This is repeated in a Hikvision USA blog post about fever cameras:
Hikvision did not respond to our request for comment.
Update 5/28/20: Hikvision has now changed the disclaimer on its blog posts from 'not medical devices' to 'not FDA approved medical devices':
Invid Tech CEO Joe Troiano doubled down on this claim when IPVM reached him, stating Invid Tech's products "do not qualify as medical devices":
InVid Tech does not have a camera system intended for use in the diagnosis of any disease or any other condition. InVid Tech is not offering a cure, mitigation, treatment, or prevention of any illnesses, in man or animal. And because of this, our products do not qualify as medical devices.
UPDATE: InVid Tech has changed its position with its disclaimer now reading their products "are not FDA approved medical devices":
This statement is technically correct (here is the list of fever detection thermography devices with FDA approval and Sunell / InVid Tech is not one of them). Again, though, these InVid Tech products are still medical devices even without FDA approval. The FDA announced it temporarily "does not intend to object" to fever detectors that don't have FDA approval during the pandemic, but it still considers these products medical devices.
What the FDA Actually Says
Many firms believe that including a claim of not being a medical device on their fever cameras makes them, somehow, no longer considered medical devices. This is false.
The FDA referred IPVM to its official policy on this, How To Determine If Your Product Is A Medical Device, which states that a product is a medical device not based on labeling but on whether it is:
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 animal
Clearly, the fever cameras part of the current pandemic-induced Gold Rush are intended to help "in the diagnosis of disease" (by helping find fevers) and aid in the "mitigation" and "prevention" of disease, i.e. COVID-19.
FDA Already Said Fever Cams Are Medical Devices
In its guidance on fever cameras last month, the FDA repeatedly stated that it considers fever cameras medical devices and under its regulatory purview:
Telethermographic systems are [medical] 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
No "Right To Declare" That Your Camera Isn't A Medical Device
Bradley Merrill Thompson, an attorney and consultant focused on FDA regulation of medical devices, has told IPVM that 'not a medical device' disclaimers are legally meaningless:
A company doesn't have the right to declare whether their product is a medical device or not. Merely disclaiming medical device status does not make it so [...] 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 [emphasis added]
Medical Devices Can Be Used In Non-Medical Settings
yes, sell and install these cameras in non-medical settings. Unless you are contracting with a hospital or other medical facility you are not selling or installing medical grade devices intended for diagnostic or cure purposes
But the FDA makes no distinction between fever cameras in hospitals vs. supermarkets. If the camera's purpose is to detect elevated body temperatures in order to find fevers, it is a medical device, regardless of the location. The FDA explicitly says that body temp measurement devices, "including in non-medical environments", are taken into account.
IPVM sent a correction to Kirschenbaum and he has updated his analysis.
UPDATE: A commenter pointed out that Kirschenbaum's analysis still claims that some fever cams are medical devices, and some are not:
So where does that leave the alarm industry, who may be asked by customers to install these fever detection devices? I am sticking with my original recommendation: sell and install the devices. The Standard Form Commercial All in One has been updated in several ways to deal with this new service. It’s made clear that the devices are not necessarily FDA approved or medical grade. The devices are not intended for medical purposes, treatment or cure. [emphasis added]
This is incorrect; all fever cameras are medical devices. We've requested a correction from Kirschenbaum and will update.
Why This Matters
Companies that use 'not a medical device' marketing are misleading buyers into not properly considering the performance, regulatory and legal risks of these devices. As the FDA has detailed in its latest guidance of correct operation for 'fever cameras', these medical devices work effectively only when they are properly and precisely set up and operated, which many companies are largely ignoring, raising health risks to the public.
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