21 CFR 878.4490
Absorbable hemostatic agent and dressing
21 CFR 878.4490 is the regulation titled “Absorbable hemostatic agent and dressing” in 21 CFR Part 878, General and Plastic Surgery Devices. Since 2021, 1 FDA warning letter has cited it.
- 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 812.100, 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 878.4490 (eCFR, as of Sep 1, 2026)
(a) Identification. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 878.4490.
- 21 CFR 812.100General responsibilities of investigators1 letter cites both
- 21 CFR 812.140Records1 letter cites both
- 21 CFR 812.150Reports1 letter cites both
- 21 CFR 812.20Application1 letter cites both
- 21 CFR 812.3Definitions1 letter cites both
- 21 CFR 812.40General responsibilities of sponsors1 letter cites both
- 21 CFR 812.46Monitoring investigations1 letter cites both
Latest letters citing it
The letter citing 21 CFR 878.4490 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.