21 CFR 878.4022
§ 878.4022 Hydrogel wound dressing and burn dressing.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.4022, § 878.4022 Hydrogel wound dressing and burn dressing, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90409
- Permanent ID
ys:prov:90409@1- SHA-256
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Full text
(a) Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.