21 CFR 890.5550
21 CFR 890.5550 is the regulation in 21 CFR Part 890, Physical Medicine Devices. 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 807.81, 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
- 02022
- 02023
- 12024
- 02025
- 02026
The regulation
The text of this section is not in the saved copy.
Text from eCFR.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 890.5550.
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.20Management responsibility1 letter cites both
- 21 CFR 820.22Quality audit1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
- 21 CFR 820.50Purchasing controls1 letter cites both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1 letter cites both
- 21 CFR 876.5020External penile rigidity devices1 letter cites both
Latest letters citing it
The letter citing 21 CFR 890.5550 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.