21 CFR 820.65
Traceability
21 CFR 820.65 is the regulation titled “Traceability” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 1 FDA warning letter has cited it.
Part 820 changed when FDA's Quality Management System Regulation took effect on February 2, 2026. This is the earlier text these letters cite.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 803.17, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 12025
- 02026
The regulation
Read the text of 21 CFR 820.65 (eCFR, as of Jun 1, 2025)
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 action. Such identification shall be documented in the DHR.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.65.
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.120Device labeling1 letter cites both
- 21 CFR 820.130Device packaging1 letter cites both
- 21 CFR 820.140Handling1 letter cites both
- 21 CFR 820.150Storage1 letter cites both
- 21 CFR 820.160Distribution1 letter cites both
- 21 CFR 820.170Installation1 letter cites both
Latest letters citing it
The letter citing 21 CFR 820.65 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.