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DRG Instruments GmbH manufactured in vitro diagnostic devices (Salivary Cortisol ELISA and related products) without required premarket approval (PMA) or investigational device exemption (IDE), rendering them adulterated under federal law. The company violated 510(k) notification requirements by failing to inform FDA of major changes or modifications to the intended use of these devices before commercial distribution, also making them misbranded. An FDA inspection of the firm's Marburg, Germany facility in November 2024 identified these violations, including devices that had deviated significantly from a 2005 510(k) clearance.