eCFR Reference Browser

---

title: "21 CFR §874.5840"

source: "https://www.ecfr.gov/current/title-21/section-874.5840"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "874"

part_subject: "EAR, NOSE, AND THROAT DEVICES"

subpart_code: "F"

subpart_subject: "Therapeutic Devices"

section_number: "874.5840"

section_subject: "Antistammering device."

cfr_reference: "21 CFR 874.5840"

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 antistammering device is a device that electronically generates a noise when activated or when it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech.

(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 § 874.9.

§874.5840 - Antistammering device.