CFR section
21 CFR 803.17(b): 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(b) |
|---|---|
| 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 |
| Regulation text (excerpt) | (b) Documentation and recordkeeping requirements for: (1) Information that was evaluated to determine if an event was reportable; (2) All medical device reports and information submitted to manufacturers and/or us; (3) Any information that was evaluated for the purpose of preparing the submission of annual reports; and (4) Systems that ensure access to information that facilitates timely followup and inspection by us. |
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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.