CFR section
21 CFR 820.65: Traceability
PART 820-QUALITY SYSTEM REGULATION · Subpart F-Identification and Traceability
Key facts
| Citation | 21 CFR 820.65 |
|---|---|
| Section | Traceability |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart F-Identification and Traceability |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective… |
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- 1–9 Warning letters citing this section
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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.