FDA lifts requirements for fever screening devices
Telethermographic devices originally intended for industrial, construction and commercial use can be repurposed to assist in initial screening for fever and triage of individuals in high traffic areas such as airports and businesses under guidance issued by the US Food and Drug Administration (FDA).The guidance was issued for the duration of the public health emergency related to coronavirus disease (COVID-19).
“The 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,” according to FDA.
FDA explains that whether telethermographic devices are regulated as medical devices hinges on the intended use of the device. “These products are devices when they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease,” FDA writes. When these devises are used for industrial or other applications, they are not regulated as devices.
Under the enforcement policy, FDA says it will waive 510(k) submission and other regulatory requirements for telethermographic systems meant for adjunctive diagnostic screening, including ones that were not previously intended for medical purposes, so long as they do not create an undue risk.
Devices marketed under the policy will also not be required to submit reports of correction and removal requirements or comply with registration and listing, quality system regulation and unique device identification (UDI) requirements.
They must, however, be tested and labeled in accordance with standard IEC 80601-2-56:2017 or an alternative performance standard that would provide similar results. Additional labeling recommendations should be met as well. Labels should prominently note that screening via telethermographic device can neither diagnose or rule out COVID-19 and that the finding of fever must be confirmed with either an FDA-approved noncontact infrared thermometer or clinical-grade contact thermometer. Labels also should clearly describe any needed routine calibration, information regarding the device’s blackbody reference source, the reference body site (oral, tympanic membrane) used for estimation, and more.
The agency notes that use of telethermographic screening can be a useful public health tool during the COVID-19 pandemic, particularly in high-density settings such as businesses and factories and where there is a shortage of other fever assessment products.
Guidance