eCFR Reference Browser

---

title: "21 CFR §882.1561"

source: "https://www.ecfr.gov/current/title-21/section-882.1561"

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: "882.1561"

section_subject: "Evoked photon image capture device."

cfr_reference: "21 CFR 882.1561"

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. An evoked photon image capture device is a prescription, electrically powered device intended for use as a noninvasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes.

(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 § 882.9.

§882.1561 - Evoked photon image capture device.