Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1At the start-up of 2020, Covid-19 had been sweeping through the mainland of China, and now is getting threatening worldwide. From the occurrence of the epidemic to today, Sunell's ''panda camera'' -- Body Temperature Measurement System played an important role in the work of prevention and control of epidemic. It has become the guardians for thousands of prevention and control site and points worldwide.
Passage 2FIGHTING CORONAVIRUS WE ARE AT THE FRONTIER!
Passage 3The Screening Cameras are offered for sale in the United States without marketing approval, clearance, or authorization from FDA.
Passage 4your products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).
Passage 5Your products are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce these products into interstate commerce for commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k).