21 CFR 830.50
Changes that require use of a new device identifier
21 CFR 830.50 is the regulation titled “Changes that require use of a new device identifier” in 21 CFR Part 830, Unique Device Identification. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 801.20, in 1 letter
- Closed out
- 100% 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
- 12022
- 02023
- 02024
- 02025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 830.50 most often, as written in the letters.
- 1 letterFailure to ensure that the label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of 21 CFR 801 Subpart B and 21 CFR Part 830, as required by 21 CFR 801.20(a)
The regulation
Read the text of 21 CFR 830.50 (eCFR, as of Sep 1, 2026)
(a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model.
(b) Whenever you create a new device package, you must assign a new device identifier to the new device package.
[78 FR 58825, Sept. 24, 2013]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 830.50.
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
- 21 CFR 801.3Definitions1 letter cites both
- 21 CFR 820.120Device labeling1 letter cites both
- 21 CFR 820.181Device master record1 letter cites both
- 21 CFR 820.200Servicing1 letter cites both
- 21 CFR 820.40Document controls1 letter cites both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1 letter cites both
- 21 CFR 830.300Devices subject to device identification data submission requirements1 letter cites both
Latest letters citing it
The letter citing 21 CFR 830.50 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.