CFR section
21 CFR 803.50(b)(2): If I am a manufacturer, what reporting requirements apply to me?
PART 803-MEDICAL DEVICE REPORTING · Subpart E-Manufacturer Reporting Requirements
Key facts
| Citation | 21 CFR 803.50(b)(2) |
|---|---|
| Section | If I am a manufacturer, what reporting requirements apply to me? |
| Part | PART 803-MEDICAL DEVICE REPORTING |
| Subpart | Subpart E-Manufacturer Reporting Requirements |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (2) You are responsible for obtaining and submitting to us information that is incomplete or missing from reports submitted by user facilities, importers, and other initial reporters. |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.