{"data":{"id":"us/21-cfr-878.4660","jurisdiction":"us","citation":"21 CFR 878.4660","heading":"Skin marker.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart E—Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"e2fc75280fcf95cee8ff42f963d4881f3b0be7822a08053fef8e170f110ad8f1","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.4635","next":"us/21-cfr-878.4670"},"notice":"GroundRules: Original legal text. Not legal advice."}