CFR section
21 CFR 803.18(d)(3): What are the requirements for establishing and maintaining MDR files or records that apply to me?
PART 803-MEDICAL DEVICE REPORTING · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 803.18(d)(3) |
|---|---|
| Section | What are the requirements for establishing and maintaining MDR files or records 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) | (3) You must maintain the device complaint files established under this section at your principal business establishment. If you are also a manufacturer, you may maintain the file at the same location as you maintain your complaint file under part 820 of this chapter. You must permit any authorized FDA employee, at all reasonable times, to access, to copy, and to verify the records required by this part. |
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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.