Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in IPVM, in “FDA Gives Guidance on ‘Coronavirus’ Thermal Fever Detection Systems,” by Charles Rollet. (Read the full version – subscription required.)
Following is an excerpt:
The US FDA has given IPVM guidance on the use of thermal fever detection systems being marketed for coronavirus, as an explosion of such devices has occurred in the past month.
While some companies are marketing these as a coronavirus solution, such activity is potentially illegal in the USA without some form of FDA clearance or approval.
In this post, we explain what equipment is concerned, what levels of approval is required, current solutions available, and more …
Update: ‘Not A Medical Device’ Disclaimers Not Valid
Some companies worried about FDA regulation are selling thermal cameras with disclaimers stating ‘this is not a medical device and not meant to diagnose disease’. However, it doesn’t matter if the company says ‘this is not a medical device’, what matters is the intended use of the product.
The FDA states that a medical device is a product “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 animals” [emphasis added]. If the cameras are intended to be used to screen fevers, then the intended use is clearly medical.
Bradley Merrill Thompson, an attorney and consultant focused on FDA regulation of medical devices, told IPVM:
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, as gleaned from the evidence with regard to how it is designed and marketed.