21 CFR Chapter I Subchapter H – Medical Devices – Part 801 Labeling From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 801 Labeling". 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 June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 800 General From Food and Drug Administration (FDA) 🇺🇸 21 CFR Chapter I Subchapter H - Medical Devices - Part 800 General: A regulation governing medical 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 June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
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
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for industry and FDA staff on regulatory requirements for hearing aid devices and personal sound amplification products. 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 October 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 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
Noise Claims in Hearing Aid Labeling - Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Guidance document on labeling of hearing aids, addressing noise claims and premarket requirements for the industry. 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
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
Reply Letter from the General Office of the Food and Drug Administration on Issues Related to the Operation of Exempted Behind-the-Ear Digital Hearing Aids From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2015-10522 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 July 14, 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 recognition of Jinan Medical Devices Quality Supervision and Inspection Center on hearing aids and other 11 products and projects testing qualifications notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2008-10276 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 February 5, 2008 Other (Public Domain) 0 reuses 0 favorites