21 CFR 874.3730
§ 874.3730 Laryngeal prosthesis (Taub design).
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.3730, § 874.3730 Laryngeal prosthesis (Taub design), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90225
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Full text
(a) Identification. A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.
(b) Classification. Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.