21 CFR 880.5300
§ 880.5300 Medical absorbent fiber.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.5300, § 880.5300 Medical absorbent fiber, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90533
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Full text
(a) Identification. A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.