21 CFR Chapter I Subchapter H – Medical Devices – Part 874 Ear, Nose, and Throat Devices

Name: 21 CFR Chapter I Subchapter H – Medical Devices – Part 874 Ear, Nose, and Throat Devices
Creator: Food and Drug Administration
Keywords: 21-cfr,510k,accessories,analysis,approval,bone,calibrators,catheters,contacts,cosmetics,cushions,design,diagnostics,drugs,ear,electrode,exemptions,hearing-aid,implants,lasers,materials,medical-devices,nasal,noise,nose,pre-market,pre-market-approval,prostheses,prosthetics,provisions,regulations,requirements,stimulators,surgery,surgical,surgical-instruments,test-devices,testing,throat,treatment,wireless

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Regulation

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Medical Devices

Last updated

January 9, 2023

Description

This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 874 Ear, Nose, and Throat Devices".

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Food and Drug Administration (FDA) 🇺🇸

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United States

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Other (Public Domain)

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5 Main files

Subpart A – General Provisions

Updated on January 5, 2017

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-874/subpart-A
Permalink: https://data.openrid.co/en/datasets/r/4f3bbf6c-f9fd-48ef-ac6e-4870d021b10c
MIME Type: text/html

Created on: February 6, 2024
Modified on: January 5, 2017

Scope. Effective dates of requirement for premarket approval. Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B – Diagnostic Devices

Updated on January 1, 2020

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-874/subpart-B
Permalink: https://data.openrid.co/en/datasets/r/f96e8a18-d314-439d-a635-ab56352a1081
MIME Type: text/html

Created on: February 6, 2024
Modified on: January 1, 2020

Audiometer. Acoustic chamber for audiometric testing. Short increment sensitivity index (SISI) adapter. Audiometer calibration set. Auditory impedance tester. Earphone cushion for audiometric testing. Electronic noise generator for audiometric testing. Electroglottograph. Gustometer. Olfactory test device. Air or water caloric stimulator. Surgical nerve stimulator/locator. Toynbee diagnostic tube.

Subpart D – Prosthetic Devices

Updated on October 18, 2022

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-874/subpart-D
Permalink: https://data.openrid.co/en/datasets/r/47836362-115c-4fe0-83c6-c40f2a648c89
MIME Type: text/html

Created on: February 6, 2024
Modified on: October 18, 2022

Air-conduction hearing aid. Bone-conduction hearing aid. Wireless air-conduction hearing aid. Hearing aid calibrator and analysis system. Tympanic membrane contact hearing aid. Group hearing aid or group auditory trainer. Self-fitting air-conduction hearing aid. Master hearing aid. Active implantable bone conduction hearing system. Battery-powered artificial larynx. Tinnitus masker. Middle ear mold. Partial ossicular replacement prosthesis. Total ossicular replacement prosthesis. Prosthesis modification instrument for ossicular replacement surgery. Ear, nose, and throat synthetic polymer material. Mandibular implant facial prosthesis. Laryngeal prosthesis (Taub design). Sacculotomy tack (Cody tack) Endolymphatic shunt. Endolymphatic shunt tube with valve. Tympanostomy tube. Nasal dilator. Tympanostomy tube with semipermeable membrane. Transcutaneous air conduction hearing aid system.

Subpart E – Surgical Devices

Updated on January 9, 2023

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-874/subpart-E
Permalink: https://data.openrid.co/en/datasets/r/d6a6ca78-682b-45e1-8ab9-d7ac1959cb06
MIME Type: text/html

Created on: February 6, 2024
Modified on: January 9, 2023

Epistaxis balloon. Ear, nose, and throat bur. Nasopharyngeal catheter. Eustachian tube balloon dilation system. Ear, nose, and throat electric or pneumatic surgical drill. Ear, nose, and throat fiberoptic light source and carrier. Ear, nose, and throat manual surgical instrument. Powered insertion system for a cochlear implant electrode array. Argon laser for otology, rhinology, and laryngology. Ear, nose, and throat microsurgical carbon dioxide laser. Bronchoscope (flexible or rigid) and accessories. Esophagoscope (flexible or rigid) and accessories. Mediastinoscope and accessories. Laryngostroboscope. Nasopharyngoscope (flexible or rigid) and accessories. Otoscope. Intranasal splint. Bone particle collector.

Subpart F – Therapeutic Devices

Updated on January 5, 2017

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URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-874/subpart-F
Permalink: https://data.openrid.co/en/datasets/r/b0747571-1204-47c3-a806-0116484f691f
MIME Type: text/html

Created on: February 6, 2024
Modified on: January 5, 2017

Ear, nose, and throat drug administration device. Ear, nose, and throat examination and treatment unit. Suction antichoke device. Tongs antichoke device. Powered nasal irrigator. External nasal splint. Antistammering device. External upper esophageal sphincter compression device.

21 CFR Chapter I Subchapter H – Medical Devices – Part 874 Ear, Nose, and Throat Devices

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