Reporting Problems to FDA
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with a product. We encourage health care providers and patients who suspect a problem with a medical imaging device to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Medical device manufacturers, distributors, importers, and device user facilities (which include many health care facilities) must comply with the Medical Device Reporting (MDR) Regulations of 21 CFR Part 803.