21 CFR 880.5440
Intravascular administration set
21 CFR 880.5440 is the regulation titled “Intravascular administration set” 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
- 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
- 02025
- 12026
The regulation
Read the text of 21 CFR 880.5440 (eCFR, as of Sep 1, 2026)
(a) Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
(b) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 15798, Mar. 21, 2001]
Text from eCFR as of Sep 1, 2026.
Latest letters citing it
The letter citing 21 CFR 880.5440 that FDA posted most recently.
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