FDA WARNING_LETTER - Shenzhen Sunell Technology Corporation - March 04, 2021

On March 4, 2021, the FDA issued a Warning Letter to Shenzhen Sunell Technology Corporation after reviewing their website on February 26, 2021. The FDA found that Sunell Technology was offering "Screening Cameras" (Bi-Spectrum Fever Screening Network Camera, Temperature Screening Thermographic Network Bullet Camera, AI Fever Screening Network Camera With Integrated Blackbody, and Fever Screening Body Temperature Measurement Network Camera Accurate ±0.3℃) for sale in the U.S. with claims indicating their use for mitigating, preventing, treating, diagnosing, or curing COVID-19.

The FDA determined these products are devices under section 201(h) of the Act. The products are adulterated under section 501(f)(1)(B) of the Act because the firm lacks premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act for failure to notify the FDA of intent to introduce these products into interstate commerce as required by section 510(k).

The letter highlights public health risks associated with unapproved telethermographic devices, including inaccurate temperature detection, which could lead to reduced adherence to infection control guidelines. The FDA cited website statements promoting simultaneous scanning of multiple individuals (e.g., "up to 45 Targets").

Sunell Technology is required to immediately cease the sale of these adulterated and