Regulatory Affairs – FDA Defines Correct Operation of Fever Cameras

By | October 19, 2020

The US FDA has now defined the correct operation of “Thermal Imaging Systems”, colloquially known as “fever cameras”.










Many in video surveillance have interpreted the FDA’s decision to temporarily lift 510(k) clearance requirements for fever cameras to mean that ‘anything goes’, ignoring well-established global standards.

However, this latest FDA guidance show that even amid a fever camera Gold Rush, the agency believes such systems need to be set up and operated “correctly”.

In this we post, we examine this new FDA document, including:

  • Background: FDA Studies Show Fever Cam Operation Importance
  • FDA Statement to IPVM
  • Fever Cameras “Only Effective” Under These Conditions
  • “Careful” Setup Needed
  • What Is A Right Environment?
  • Secondary Confirmation A Must
  • Remove Hats, Glasses, Hair Obstructions/ Wait 15 Minutes
  • Process People One At A Time, No “Mass Fever Screening”
  • Locations Recommended: Airports, Offices, Supermarkets, Concerts, Hospital ERs
  • No Distance Recommendation, But Clearly Close
  • Blackbody Only Required If Manufacturer Recommends

Full post on IPVM