CFR section
21 CFR 803.40(b): If I am an importer, what reporting requirements apply to me?
PART 803-MEDICAL DEVICE REPORTING · Subpart D-Importer Reporting Requirements
Key facts
| Citation | 21 CFR 803.40(b) |
|---|---|
| Section | If I am an importer, what reporting requirements apply to me? |
| 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) | (b) Reports of malfunctions. You must submit a report to the manufacturer as soon as practicable but no later than 30 calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or through your own research, testing, evaluation, servicing, or maintenance of one of your devices, that reasonably suggests that one of your devices has malfunctioned and that this device or a similar device that you market would be… |
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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.