Medical Device Reporting for Distributors

摘要

This guidance is directed to distributors of domestic and imported medicaldevices. FDA is requiring medical device distributors to report deaths and serious injuries that are attributed to medical devices. Distributors are also required to report certain device malfunctions and to annually submit a report to FDA certifying the number of medical device reports filed during the preceding year or that no reports were filed. The Medical Device Reporting (MDR) regulation provides mechanism for FDA to identify and monitor significant adverse events involving medical devices, so that problems may be detected and corrected in a timely manner. These reports enable FDA to protect the public health by helping to ensure that devices are not adulterated or misbranded and are otherwise safe and effective for their intended use.