CFR section
21 CFR 803.30(a)(2): If I am a user facility, what reporting requirements apply to me?
PART 803-MEDICAL DEVICE REPORTING · Subpart C-User Facility Reporting Requirements
Key facts
| Citation | 21 CFR 803.30(a)(2) |
|---|---|
| Section | If I am a user facility, what reporting requirements apply to me? |
| 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) | (2) Reports of serious injury. You must submit a report to the manufacturer of the device no later than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility. If the manufacturer is not known, you must submit the report to us. You must report information required by § 803.32. Reports sent to the Agency must be submitted in accordance with the… |
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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.