FDA 483 - Neurodynamics, Inc. - February 28, 2024

Neurodynamics, Inc., a medical device manufacturer in New York, NY, was inspected and cited for failing to maintain written Medical Device Reporting (MDR) procedures. Specifically, the firm lacked an electronic MDR (eMDR) procedure and had not established an Electronic Submissions Gateway (ESG) account to report serious injuries and deaths. This indicates a significant lapse in their post-market surveillance and reporting obligations.