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