Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 803 - Medical Device Reporting |
Subpart C - User Facility Reporting Requirements |
§ 803.30 - If I am a user facility, what reporting requirements apply to me? |
§ 803.32 - If I am a user facility, what information must I submit in my individual adverse event reports? |
§ 803.33 - If I am a user facility, what must I include when I submit an annual report? |