[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.4660]

[Page 402-403]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878_GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                       Subpart E_Surgical Devices
 
Sec. 878.4660  Skin marker.

    (a) Identification. A skin marker is a pen-like device intended to 
be used to

[[Page 403]]

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 Sec. 878.9.

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