21 CFR 876.5665
§ 876.5665 Water purification system for hemodialysis.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.5665, § 876.5665 Water purification system for hemodialysis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90353
- Permanent ID
ys:prov:90353@1- SHA-256
5fafd3cf25bfd809da86db78f8a4b66ed390f922db90b7531275867e12f22b5d
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.
(b) Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.