CFR section
21 CFR 803.42(e)(1): If I am an importer, what information must I submit in my individual adverse event reports?
PART 803-MEDICAL DEVICE REPORTING · Subpart D-Importer Reporting Requirements
Key facts
| Citation | 21 CFR 803.42(e)(1) |
|---|---|
| Section | If I am an importer, what information must I submit in my individual adverse event reports? |
| Part | PART 803-MEDICAL DEVICE REPORTING |
| Subpart | Subpart D-Importer Reporting Requirements |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (1) An indication that this is an importer report (by marking the importer box on the form); |
At a glance
- 1–9 Inspections citing this section
- None Warning letters citing this section
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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.