Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistOmnisense Systems Pte Ltd. was cited for marketing the Sentry MK4 fever detection system as an unapproved medical device intended to mitigate, prevent, and detect COVID-19, based on claims made on their website and product brochure. The company violated FDA regulations by failing to obtain required device clearance or approval before marketing a product with intended COVID-19 claims, and by making disease claims that classified the product as a medical device under the Federal Food, Drug, and Cosmetic Act. The FDA identified specific marketing statements positioning the Sentry MK4 as a pandemic defense solution and a successor to systems that "protected" organizations from COVID-19, establishing the company's intent to position it as a COVID-19 diagnostic or preventive tool without proper regulatory authorization.