CFR section
21 CFR 803.33(a): If I am a user facility, what must I include when I submit an annual report?
PART 803-MEDICAL DEVICE REPORTING · Subpart C-User Facility Reporting Requirements
Key facts
| Citation | 21 CFR 803.33(a) |
|---|---|
| Section | If I am a user facility, what must I include when I submit an annual report? |
| Part | PART 803-MEDICAL DEVICE REPORTING |
| Subpart | Subpart C-User Facility Reporting Requirements |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (a) You must submit to us an annual report on Form FDA 3419. You must submit an annual report by January 1, of each year. You may obtain this form on the internet at: https://www.fda.gov/media/72292/download. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.