CFR section
21 CFR 803.18(d)(2): 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)(2) |
|---|---|
| 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) | (2) You must retain copies of the required device incident records for a period of 2 years from the date of inclusion of the record in the file or for a period of time equivalent to the expected life of the device, whichever is greater. You must maintain copies of these records for this period even if you no longer distribute the device. |
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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.