CFR section
21 CFR 803.17(a)(2): What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
PART 803-MEDICAL DEVICE REPORTING · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 803.17(a)(2) |
|---|---|
| Section | What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? |
| Part | PART 803-MEDICAL DEVICE REPORTING |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and |
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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.