FDA WARNING_LETTER - Draegar Medical Systems, Inc. - September 20, 2019

The FDA issued a Warning Letter to Draegerwerk AG & Co. KGaA on January 17, 2020, following an inspection of their Andover, MA facility from August 20 to September 20, 2019. The inspection revealed that their IACS M540 (Infinity Acute Care System) device is adulterated because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption. The device is also misbranded as the firm failed to submit a 510(k) premarket notification for significant modifications that could affect safety or effectiveness, potentially leading to patient injury or death (e.g., undetected life-threatening arrhythmias).

Additionally, the devices are adulterated under 21 CFR Part 820, as manufacturing, packing, storage, or installation methods do not conform to Quality System regulation requirements. Specific violations include: 1. Failure to establish and maintain procedures for validating device design, including risk analysis (21 CFR § 820.30(g)). 2. Failure to establish and maintain procedures for verifying device design (21 CFR § 820.30(f)). 3. Failure to establish and maintain procedures for defining and documenting design output (21 CFR § 820.30(d)). 4. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA) (