21 CFR 878.4660
§ 878.4660 Skin marker.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 878.4660, § 878.4660 Skin marker, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90446
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Full text
(a) Identification. A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.
(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 § 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.