(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.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]