eCFR Reference Browser

---

title: "21 CFR §882.1310"

source: "https://www.ecfr.gov/current/title-21/section-882.1310"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "882"

part_subject: "NEUROLOGICAL DEVICES"

subpart_code: "B"

subpart_subject: "Neurological Diagnostic Devices"

section_number: "882.1310"

section_subject: "Cortical electrode."

cfr_reference: "21 CFR 882.1310"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.

(b)Classification. Class II (performance standards).

§882.1310 - Cortical electrode.