CFR section
21 CFR 803.17(a)(1): 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)(1) |
|---|---|
| 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, Food/Cosmetics |
| Regulation text (excerpt) | (1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements; |
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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.