FDA Issues Enforcement Policy for Telethermographic Systems During COVID-19
On April 16, the White House Coronavirus Task Force issued a 3-phase approach for getting the country back to work (i.e., “Opening Up America Again”). In the wake of this announcement, the critical need for diagnostic testing and other screening tools has become amplified. One such tool is telethermographic systems (sometimes referred to as thermal imaging) that can be used to rapidly provide an initial screen of individuals’ temperatures in a crowded setting.
To this end, also on April 16, FDA issued an Enforcement Discretion Policy directed at telethermographic systems for initial temperature assessment for triage use in high throughput areas such as airports, businesses, warehouses, and factories. This Policy can be found here. As with all of the other Enforcement Discretion Policies issued thus far, FDA intends for this Policy to remain in effect for the duration of the COVID-19 public health emergency.
FDA’s newly released Enforcement Policy applies only to telethermographic systems that are intended for adjunctive diagnostic screening. FDA’s Enforcement Policy applies to products that are subject to FDA’s longstanding regulation as Class I non-exempt devices (product code LHQ) but that has been modified in certain ways deemed as permissible under the Enforcement Policy, or (2) products that are typically not considered a medical device but that FDA has deemed permissible for intended medical use so long as they otherwise meet the requirements set forth in the Enforcement Policy.
The Enforcement Policy is intended to apply to all telethermographic systems that are intended for medical purposes for the duration of the COVID-19 public health emergency. FDA considers a telethermographic system to be a medical device when it is intended for a medical purpose, such as a measure of the self-emanating infrared radiation that reveals the relevant temperature variations of the body surfaces.
As part of its assessment of whether the product a telethermographic system is intended for medical use, FDA will consider product labeling (i.e., whether intended for use by a health care professional and/or use in a health care facility or environment). Notably, however, FDA will also consider whether the product is labeled for body temperature measurements for diagnostic purposes, including such use in non-medical environments (e.g., airport), and any other medical use.
Relaxation of Certain Requirements Otherwise Generally Applicable to Telethermographic Systems Intended for Medical Use
In the conventional (non-COVID-19 pandemic) regulatory environment, telethermographic systems intended for adjunctive diagnostic screening are subject to FDA’s premarket clearance (“510-k”) requirements. However, to help ensure the availability of these products during the public health emergency, FDA announces in its Enforcement Policy that it does not intend to object to the distribution and use of these intended for an initial body temperature assessment for triage use notwithstanding the failure to comply with the following FDA requirements: pre-marketing clearance (i.e., 510(k)); certain reporting requirements; registration and listing; quality system requirements; and unique identification requirements.
To be deemed to be within the scope of this FDA Enforcement Policy, the following are key: (1) the product is intended to be used for adjunctive diagnostic screening only (i.e., elevated body temperature must be confirmed with another evaluation method); and (2) the product does not create undue risk.
To avoid a product being deemed to create “undue risk” and thus falling outside of the Enforcement Policy, FDA recommends adherence to numerous performance standards and labeling, including labeling clearly identifying that the product is intended for adjunctive use only.
A summary of the performance and labeling requirements are summarized below.
Performance and Labeling
FDA recommends that the product is tested and labeled consistent with IEC 80601-2-59:2017 or alternative performance specifications that provide similar results. Potential alternative considerations are discussed in greater detail on p. 5 of the Enforcement Policy. These potential alternatives include, but are not limited to, an assessment that addresses all potential safety issues, including electric safety; electromagnetic compatibility; mechanical safety; excessive temperature and other hazards; the accuracy of controls, instruments, and information display; considerations for software associated with Programmable Electronic Medical Systems; and usability.
In addition to satisfying the recommended performance standards, FDA’s Enforcement Policy also includes numerous labeling recommendations to help ensure that a telethermographic device does not create an “undue risk.” These labeling considerations are discussed in detail on pp. 5-6 of the Enforcement Policy. Examples of recommendations to avoid creating “undue risk” include, but are not limited to, labeling that includes:
- a prominent notice that the measurement not be solely or primarily relied upon to diagnose or exclude e a diagnosis of COVI-19 or any other disease;
- a clear statement that (i) elevated body temperature should be confirmed with secondary evaluation methods (non-contact infrared thermometer or clinical grade contract thermometer); (ii) public health officials, through their experience with the device in the particular environment of use, should determine the significance of any fever or elevated temperature based on the skin temperature measurement; (iii) technology should be used to measure only one subject’s temperature at a time; and (iv) visible thermal patterns are only intended for locating the points from which to extract the thermal measurement;
In terms of performance-related information, FDA recommends that the labeling also include:
- device-performance specifications (and methodology and frequency of any needed calibration);
- how to use the thermal image to make a temperature measurement;
- description and purpose of the blackbody reference source and its importance in obtaining an accurate temperature assessment;
- reference body site used for temperature estimate;
- description of how different environmental and system set-up factors can affect the measurement;
- different factors to consider in the design of the facility protocol;
- installation procedures and qualification testing; and
- appropriate imaging distance.
Finally, FDA also recommends that the labeling (1) reference, and is consistent with, the guidelines in ISO/TR 13154:2017; and (2) highlight the differences in design, indications, or functions as applicable, compared to the unmodified, FDA-cleared version of the product or, alternatively includes a clear statement that the device is not FDA-cleared or approved.
The FDA’s new Enforcement Policy directed at expanding the availability of telethermographic systems is well-timed, particularly given the newly announced framework for “Opening Up American Again.” But there are numerous labeling and performance standards that such products must comply with in order to stay within the scope of this Policy.
Critically, although modifications to current products are deemed permissible, the Policy does not include any additional information about modifications that could be permissible, other than one example of a labeling modification.