KEN KIRSCHENBAUM, ESQ
ALARM - SECURITY INDUSTRY LEGAL EMAIL NEWSLETTER / THE ALARM EXCHANGE
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Can you promote and install temperature device cameras
May 21, 2020
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Can you promote and install temperature device
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There's been a lot of discussion on this topic. The quick answer is, 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. If a supermarket or shopping mall wants to install the temperature cameras to hopefully persuade the public that the facility has taken precautions to protect health and safety, you can install the devices. Use the Commercial All in One. Describe the system in the Schedule of equipment and services.
The FDA [Food and Drug Agency] which regulates medical devices has issued guidelines and what it calls non-binding recommendations, "Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff; April 2020"
The significance of the report is that the FDA recognizes that the temperature cameras are being used for non-medical purposes. Medical purposes are diagnostic and cure. That is not why alarm customers are installing the devices.
When you promote and sell the devices be sure to state that they are non-medical and not intended for medical diagnosis or treatment. Here is the pertinent part of the report:
" 4 Telethermographic systems may be marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications. Because they are not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, when marketed for these non-medical applications, FDA device marketing authorization is not required, and all the other medical device requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of these products. Telethermographic systems are 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. When evaluating whether these products are intended for a medical purpose, among other considerations, FDA will consider whether: 1) They are labeled or otherwise intended for use by a health care professional; 2) They are labeled or otherwise for use in a health care facility or environment; and 3) They are labeled for an intended use that meets the definition of a device, e.g., body temperature measurement for diagnostic purposes, including such use in non-medical environments (e.g., airports)."
You will note that the guideline is "non-binding". I suppose that means something in the FDA world, but for our purposes I suppose that it means FDA can change its mind. In the meantime, you can rely on the guideline.
Special thanks to John Honovich from IPVM for bringing this to my attention. You can read the report here: https://www.fda.gov/media/137079/download
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Ken Kirschenbaum,Esq
Kirschenbaum & Kirschenbaum PC
Attorneys at Law
200 Garden City Plaza
Garden City, NY 11530
516 747 6700 x 301
ken@kirschenbaumesq.com
www.KirschenbaumEsq.com
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