FDA WARNING_LETTER - Opgal Optronic Industries Ltd. - February 25, 2021

The FDA issued a Warning Letter to Opgal Optronic Industries Ltd. after reviewing their website and social media on February 22 and 25, 2021. The review found that Opgal was offering "Therm-App MD" and "Therm-App MD Pro" products for sale in the U.S., claiming they mitigate, prevent, treat, diagnose, or cure COVID-19. These claims establish the products as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The products are adulterated under section 501(f)(1)(B) because Opgal lacks approved applications for premarket approval (PMA) or investigational device exemption (IDE) as required by sections 515(a) and 520(g). They are also misbranded under section 502(o) because the firm failed to notify the FDA of its intent to introduce these products into interstate commerce, as required by section 510(k). The introduction of these products into interstate commerce is prohibited under section 301(a). The FDA highlighted public health risks, especially with simultaneous scanning, and requested immediate action to cease sales of these unapproved, uncleared, and unauthorized products. Opgal must respond within 48 hours via email, detailing corrective actions, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and the firm will be added to FDA's public list of non-compliant companies.