21 CFR 878.4683
§ 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.4683, § 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90450
- Permanent ID
ys:prov:90450@1- SHA-256
ee146204a768904e3ebbc7d96723ef955dd81c77cb2f4d25a0e657cdfd6f0ec1
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Full text
(a) Identification. A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.
(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.