DRG Instruments GmbH

Warning LetterOpen

Jörg Schlöβer Managing Director DRG Instruments GmbH Frauenbergstr. 18 Marburg 35039 Hassia Germany (b)(6)@drg-diagnostics.deFEI 3002800697Issued Mar 31, 2025Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3002800697.

Violations7

Issue DateMar 31, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: DRG Instruments GmbH
Location: Jörg Schlöβer Managing Director DRG Instruments GmbH Frauenbergstr. 18 Marburg 35039 Hassia Germany (b)(6)@drg-diagnostics.de
FEI Number: 3002800697
Country: Germany
Issue Date: March 31, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

DRG Instruments GmbH FDA Warning Letter, March 31, 2025