FDA 483 - Advanced Monitored Caregiving, Inc. - November 12, 2020

Advanced Monitored Caregiving, Inc., a medical device manufacturer in New York, NY, was cited for failing to develop and maintain adequate Medical Device Reporting (MDR) procedures. Specifically, the firm lacked electronic MDR procedures for death and serious injury incidents and instructions for reporting required information on MedWatch Form 3500A. This indicates a significant lapse in critical post-market surveillance and reporting requirements for medical devices.