On 16 April 2020, FDA proclaimed that no action will be taken during the COVID-19 health emergency, against companies marketing unapproved fever detection cameras as long as they "do not create undue risk.” FDA has announced new guidance even though it does consider these products’ medical devices.
FDA greenlights telethermographic systems’ use for COVID-19 triage
FDA announced that in order to help address urgent public health concerns it “does not intend to object” to the marketing of unapproved fever scanning cameras. However, the FDA also stresses that this leniency will remain in effect only during the pandemic of Coronavirus to help apply the temperature screening strategy in order to prevent the spreading of coronavirus. Moreover, FDA has reserved the right to take action against products that will create undue risk.
In an overview of the FDA guidance regarding temperature screening cameras done by Nova Test Pro will be, the impacts of this announcement are studied keenly:
Previous Regulations of FDA Regarding Fever Screening Cameras
Prior to this announcement, the FDA considered fever screening cameras (when paired with a thermometer to confirm the fever) to be medical tools. These tools required an FDA 510(k) clearance before being marketed, a process that takes around 130 days.
However, in the new guidance announced on 16 April 2020, FDA announced that it will not enforce its own regulations and will not object to the distribution of unapproved screening cameras.
The reasoning of FDA: Fighting Shortage
In the 10-page guidance, FDA explained the reason:
“FDA is taking steps to help expand the availability of telethermographic systems and believes the policy set forth in this guidance may help address the urgent public health concerns raised by shortages of temperature measurement products such as thermometers and telethermographic systems by taking a risk-based approach and clarifying the policies that FDA intends to apply to telethermographic systems during the COVID-19 pandemic.”
A temporary policy
FDA emphasized that this guidance was only temporary and shall remain in effect until the public health emergency of coronavirus remains. According to the recent stats, the total cases of coronavirus cases reported in the USA by September 18, was 6.7M which included 198K deaths. Every day, new cases are reported, which means that given the great impact of COVID-19 this public health emergency is likely to last at least a year if not significantly longer.
FDA considered fever cameras medical devices
In this new guidance, the FDA clearly stressed that all the fever cams are considered medical devices. This blocked all the false claims by some companies about their devices not being medical devices. It means that for selling their fever detection cameras they will need FDA 510(k) clearance. Despite this, the money is likely to be made for them in immediate future because of the current leniency applied by FDA.
Fever Cams Only to Be Used with Thermometers
While the 510(k) clearance is forgone by FDA and puts fever cam companies in a lot of liberties, still some conditions were put forth. Among these conditions include fever cams not to create an "undue risk" and be for "only triage use." Which means that these cams need to be used only with a thermometer for accurate elevated body temperature measurement.
Testing and Labeling Recommendations by FDA
The FDA recommended that temperature screening cameras be tested and labeled with the following ISO standard: IEC 80601-2-59:2017.
FDA also emphasized that the measurement uncertainty of fever cams be 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 Recommendation: Camera Measure Only One Person at a Time
The use of thermal cameras that record the body temperature of more than one person at a time was also prohibited by the FDA. This was a blow for businesses that sold highly efficient cameras which recorded a temperature of 16 people or more in just a few seconds.
Other points mentioned in the guidance by FDA
- The FDA provided a long list of label Recommendations without the farther description of their application.
- The FDA also recommended that labeling should include a prominent notice that the measurement should not be to solely diagnose or exclude a diagnosis of coronavirus or any other diseases.
- The FDA suggested that their regulations are not binding and are only recommendations, yet they state that they might take action against thermal cameras that cause "undue risk."
Risks Caused by The New Guidance
This temporary policy proposed by the FDA has to lead to many new, unapproved businesses to appear in the industry. The FDA has basically given a blank check to dubious companies that have become a threat to the public. Many entrants, who do not qualify to be in the thermal camera industry, have been noticed selling cheaper, unapproved, and unreliable products to the customers. This false sale purchase can lead to false measurements of body temperature, causing a spread to coronavirus as well as resulting in harassment of healthy wellbeings.
The downside of The New Guidance
The new guidance proposed by the FDA has encouraged bad practices among the sellers as well as the buyers. Due to the temporary removal of 510(k) clearance, several unqualified small businesses jumped into the industry to take advantage of this "golden hour." This lead to a sale of unapproved and cheaper devices.
The neophytes have affected the business of reliable, and experienced companies who have been known to sell high-quality thermal cameras for years. The cheaper marketing tactics have disturbed the whole industry and confused the buyers.
This situation has to lead to false results due to selling faulty devices, causing the risk of spreading coronavirus.
Another major issue will be when this short-term policy will be discharged after the pandemic and the FDA will demand 510(k) clearance. Though, many companies might have already been disbanded by the time that happens.
The upside of FDA's New Guidance
On the contrary, the new guidance did provide clarity to the previously distraught situation. Due to the complications of legal procedures, many companies hesitated to join the industry. But now many competitive companies have emerged and presented new ideas and possibilities.
This situation also helped in the convenient availability of thermal camera devices for body temperature measurement, which was the basic cause of this guidance. It also in some way helped strategize the coronavirus control strategy in a better way by using body temperature measurement cameras.
- FDA - Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- FDA - Thermal Imaging Systems (Infrared Thermographic Systems / Thermal Imaging Cameras)
- Implementing Safety Practices for Critical Infrastructure Workers Who May Have Had Exposure to a Person with Suspected or Confirmed COVID-19