CFR section
21 CFR 803.50(b)(1): 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)(1) |
|---|---|
| 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) | (1) You must submit all information required in this subpart E that is reasonably known to you. We consider the following information to be reasonably known to you: (i) Any information that you can obtain by contacting a user facility, importer, or other initial reporter; (ii) Any information in your possession; or (iii) Any information that you can obtain by analysis, testing, or other evaluation of the device. |
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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.