Fever Cameras Are Medical Devices, Per The FDA, Dahua, Feevr, Hikvision, InVid Contrary Claims Are False

By: Charles Rollet, Published on May 28, 2020

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.

Examples Abound

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".

IPVM Image

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":

Get Notified of Video Surveillance Breaking News
Get Notified of Video Surveillance Breaking News

IPVM Image

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"):

IPVM Image

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:

IPVM Image

This is repeated in a Hikvision USA blog post about fever cameras:

IPVM Image

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':

IPVM Image

Finally, InVid Tech, which resells Sunell's 'Panda' thermal cam, also says their products "are not medical devices and cannot diagnose coronavirus infection":

IPVM Image

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":

IPVM Image

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.

IPVM Image

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

IPVM Image

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

Security industry attorney Ken Kirschenbaum posted a legal analysis originally claiming that fever cameras are not medical devices if they are installed in "non-medical settings" like supermarkets:

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.

12 reports cite this report:

X.Labs Sues FLIR on Sep 16, 2020
X.Labs, the maker of Feevr, has sued FLIR, the publicly traded thermal...
InVid Flaunts Violating FDA Guidelines on Aug 28, 2020
InVid Tech is showcasing an open violation of FDA fever screening guidelines...
School District Admits Not Following FDA Guidelines With 144, No Blackbody, Hikvision Fever Cameras on Aug 21, 2020
The Baldwin County School District has admitted it is not following FDA...
Ink Labs Relabels China YCX Fever Camera And Steals Dahua's Marketing on Jul 30, 2020
A US company marketed a 'thermal temperature scanner' as its own, selling...
2020 Mid Year Video Surveillance Industry Guide on Jul 27, 2020
The first half of 2020 has been shocking, for the world generally, and for...
The China Company (Bems) Behind a Dozen+ Western Temperature Tablets on Jul 22, 2020
While you have likely seen marketing for various temperature tablets, you...
Sperry West / Alibaba Tablet Temperature Measurement Tested on Jul 07, 2020
In April, we ordered a ~$500 temperature tablet from Alibaba. We set it to...
Dahua USA Admits Thermal Solutions "Qualify As Medical Devices" on Jul 02, 2020
Dahua USA has issued a press release admitting a controversial point in the...
Industry Study: 83% of US Temperature Screening Sellers Falsely Say Not Medical Devices on Jun 29, 2020
83% of US companies selling temperature screening devices, aka 'fever'...
Australia Dahua Faked Advertisement, Government Warns of 'Criminal Offense' for Not Registering As Medical Device on Jun 25, 2020
A full-page advertisement in a national Australia newspaper for Dahua's...
ADT: 'Fever' Cameras Are Medical Devices on Jun 15, 2020
While many manufacturers are avoiding admitting their 'fever' cameras are...
ZKTeco SpeedFace+ Are Medical Devices, Per FDA Definition, Contrary Claims Are False on Jun 12, 2020
ZKTeco SpeedFace+ series products are medical devices as defined by the US...
Comments (59) : Members only. Login. or Join.

Related Reports

ADT: 'Fever' Cameras Are Medical Devices on Jun 15, 2020
While many manufacturers are avoiding admitting their 'fever' cameras are...
ZKTeco SpeedFace+ Are Medical Devices, Per FDA Definition, Contrary Claims Are False on Jun 12, 2020
ZKTeco SpeedFace+ series products are medical devices as defined by the US...
Industry Study: 83% of US Temperature Screening Sellers Falsely Say Not Medical Devices on Jun 29, 2020
83% of US companies selling temperature screening devices, aka 'fever'...
InVid Flaunts Violating FDA Guidelines on Aug 28, 2020
InVid Tech is showcasing an open violation of FDA fever screening guidelines...
Temperature Screening From The Protection Bureau and ZKTeco Violate IEC Standards and FDA Correct Operation on Jun 22, 2020
ZKTeco and integrator The Protection Bureau are marketing an installation...
Dahua USA Admits Thermal Solutions "Qualify As Medical Devices" on Jul 02, 2020
Dahua USA has issued a press release admitting a controversial point in the...
Wrong Dahua Australia Medical Device Approved on Jul 20, 2020
Dahua's body temperature system is now in Australia's medical device...
Axis Compares Fever Camera Sellers to 9/11 on Sep 18, 2020
Axis Communications, the West's largest surveillance camera manufacturer, has...
Dahua Taunts Australian Government, Continues To Sell Illegal Fever Cameras on Aug 10, 2020
Dahua is effectively taunting the Australian government by continuing to sell...
UK Firm Markets False Fever Screening, Hikvision Disavows on Jun 30, 2020
A UK security firm falsely claimed its Hikvision-based thermal solution could...
Convergint Refuses To Fix Faked Fever Marketing, FTC Complaint Filed on Jun 19, 2020
Since Convergint has refused to fix their faked fever camera marketing, IPVM...
US Surgeon General Unwittingly Showcases Sanctioned Dahua Temperature System on Jul 28, 2020
The US' top public health spokesperson, the Surgeon General, posted a photo...
School District Admits Not Following FDA Guidelines With 144, No Blackbody, Hikvision Fever Cameras on Aug 21, 2020
The Baldwin County School District has admitted it is not following FDA...
Australia Dahua Faked Advertisement, Government Warns of 'Criminal Offense' for Not Registering As Medical Device on Jun 25, 2020
A full-page advertisement in a national Australia newspaper for Dahua's...
ISC News Fakes Fever Screening, Falsely Quotes FDA on Jun 18, 2020
ISC News, the Reed publication behind the ISC East and West trade shows, has...

Recent Reports

Temperature Tablet Shootout - Dahua, Hikvision, ZKTeco, TVT + 5 More on Sep 30, 2020
Temperature tablets, aka terminal or stations, have emerged as a 'low-cost...
New Products Show Fall 2020 Tomorrow Bosch, FLIR, Hanwha, Tyco, Avigilon More! on Sep 30, 2020
IPVM's sixth online show concludes tomorrow with our special temperature...
ButterflyMX Raises $35 Million on Sep 30, 2020
Startup ButterflyMX has raised $35 million for its smartphone based intercom...
Worst Access Control Manufacturers 2020 on Sep 30, 2020
200+ Integrators told IPVM "In the past year, what access control...
Access Control Levels and Schedules Tutorial on Sep 29, 2020
Configuring access levels and setting up schedules is central to maintaining...
Avigilon / Motorola VS Virtual ISC West on Sep 29, 2020
ISC West has historically been so dominant that no player would think of...
Dartmouth College Deploys K3 Temperature Screening on Sep 29, 2020
While Dartmouth College has a $6+ billion endowment, the College has bought...
Hanwha AI Object Detection Tested on Sep 28, 2020
Hanwha has added detection and classification of people, cars, clothing...
Favorite Access Control Manufacturers 2020 on Sep 28, 2020
200+ Integrators told IPVM "What is your favorite access control management...
OnTech Smart Services Partners With Google and Amazon To Compete With Integrators on Sep 25, 2020
A pain point for many homeowners to use consumer security and surveillance is...
The Future of Metalens For Video Surveillance Cameras - MIT / UMass / Immervision on Sep 25, 2020
Panoramic cameras using 'fisheye' lens have become commonplace in video...
Hikvision Sues Over Brazilian Airport Loss on Sep 24, 2020
Hikvision was excluded from a Brazilian airport project because it is owned...
China General Chamber of Commerce Calls Out US Politics on Sep 24, 2020
While US-China relations are at an all-time low, optimism about relations...
Verkada Disruptive Embedded Live Help on Sep 24, 2020
Call up your integrator? Have someone come by the next day? Verkada is...
IP Networking Course Fall 2020 - Last Chance - Register Now on Sep 23, 2020
Today is the last chance to register for the only IP networking course...