21 CFR Chapter I Subchapter H – Medical Devices – Part 874 Ear, Nose, and Throat Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 874 Ear, Nose, and Throat Devices". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on January 9, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Powered Insertion System for a Cochlear Implant Electrode Array From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-00008. The Food and Drug Administration (FDA, Agency, or we) is classifying the powered insertion system for a cochlear implant electrode array into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 6, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-17230. The Food and Drug Administration (FDA, we, or the Agency) is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, we define OTC hearing aids and… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 17, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-22473. The Food and Drug Administration (FDA, we, or the Agency) is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. Specifically, we propose to define OTC… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 20, 2021 Other (Public Domain) 0 reuses 0 favorites
Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers: Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for manufacturers seeking marketing clearance for protective barriers used in ear, nose, and throat endoscope sheaths. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 18, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-23464. The Food and Drug Administration (FDA or we) is classifying the self-fitting air-conduction hearing aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 28, 2019 Other (Public Domain) 0 reuses 0 favorites
ZL103_00_003e_WL Guidance document Authorisation of individual teas, cough and throat lozenges and pastilles in the notification procedure HMV4 From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document provides guidance on the authorization process for teas, cough and throat lozenges, and pastilles in the HMV4 notification procedure. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 29, 2019 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Active Implantable Bone Conduction Hearing System From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-23412. The Food and Drug Administration (FDA or we) is classifying the active implantable bone conduction hearing system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 26, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-25602. The Food and Drug Administration (FDA) is classifying the Eustachian tube balloon dilation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 24, 2016 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Tympanic Membrane Contact Hearing Aid From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-01090. The Food and Drug Administration (FDA) is classifying the tympanic membrane contact hearing aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the tympanic… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 21, 2016 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-19074. The Food and Drug Administration (FDA) is classifying the external upper esophageal sphincter (UES) compression device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 4, 2015 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-14790. The Food and Drug Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 15, 2011 Other (Public Domain) 0 reuses 0 favorites
On the accreditation of Hangzhou Quality Supervision and Inspection Center for Medical Devices on the throat stroboscopic instrument and other 274 products and projects testing qualifications notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2008-10273 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on April 16, 2008 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ear, Nose, and Throat Devices; Classification of Olfactory Test Device From Food and Drug Administration (FDA) 🇺🇸 Document number E6-8791. The Food and Drug Administration (FDA) is classifying the olfactory test device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Olfactory Test Device." The… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 7, 2006 Other (Public Domain) 0 reuses 0 favorites