21 CFR 880.6430
Liquid medication dispenser
21 CFR 880.6430 is the regulation titled “Liquid medication dispenser” in 21 CFR Part 880, General Hospital and Personal Use Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 880.9, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a biologics letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
What FDA writes when it cites it
The finding headings that cite 21 CFR 880.6430 most often, as written in the letters.
- 1 letterBecause there is evidence that APLICOR 3D is intended for uses that are different from those of legally marketed devices classified under 21 CFR 880.6430, it exceeds the limitations described in 21 CFR 880.9 and is not…
The regulation
Read the text of 21 CFR 880.6430 (eCFR, as of Sep 1, 2026)
(a) Identification. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 880.6430.
Latest letters citing it
The letter citing 21 CFR 880.6430 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.