21 CFR Chapter I Subchapter H – Medical Devices – Part 882 Neurological Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 882 Neurological 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-19720. The Food and Drug Administration (FDA or we) is classifying the digital therapy device for Attention Deficit Hyperactivity Disorder 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… 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-00497. The Food and Drug Administration (FDA, Agency, or we) is classifying the digital therapy device to reduce sleep disturbance for psychiatric conditions into class II (special controls). The special controls that apply to the device type are identified in this order 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 January 13, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Brain Stimulation Programming Planning Software From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-28603. The Food and Drug Administration (FDA, Agency, or we) is classifying brain stimulation programming planning software 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… 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 5, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-28430. The Food and Drug Administration (FDA, Agency, or we) is classifying the pediatric Autism Spectrum Disorder (ASD) diagnosis 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… 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 December 30, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Diagnostic Neurosurgical Microscope Filter From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-28160. The Food and Drug Administration (FDA or we) is classifying the diagnostic neurosurgical microscope filter 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 December 29, 2021 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Cerebrospinal Fluid Shunt System From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-28157. The Food and Drug Administration (FDA or we) is classifying the cerebrospinal fluid shunt 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 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 December 29, 2021 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Traumatic Brain Injury Eye Movement Assessment Aid From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-27227. The Food and Drug Administration (FDA or we) is classifying the traumatic brain injury eye movement assessment 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… 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 December 16, 2021 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Temporary Coil Embolization Assist Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-26926. The Food and Drug Administration (FDA or we) is classifying the temporary coil embolization assist device 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 December 13, 2021 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for Attention Deficit Hyperactivity Disorder From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-26740. The Food and Drug Administration (FDA, the Agency, or we) is classifying the transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder (ADHD) into class II (special controls). The special controls that apply to the device type are… 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 December 10, 2021 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Trunk and Limb Electrical Stimulator To Treat Headache From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-26175. The Food and Drug Administration (FDA or we) is classifying the trunk and limb electrical stimulator to treat headache 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… 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 December 2, 2021 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Conditioning Tool for Eating Disorders From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-26176. The Food and Drug Administration (FDA or we) is classifying the conditioning tool for eating disorders 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 December 2, 2021 Other (Public Domain) 0 reuses 0 favorites
Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Devices Intended To Treat Anxiety and/or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended To Treat Depression From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-27295. The Food and Drug Administration (FDA) is issuing a final order to reclassify the cranial electrotherapy stimulator (CES) device intended to treat anxiety and/or insomnia, a preamendments class III device, into class II (special controls) and subject to premarket… 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 December 20, 2019 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-04709. The Food and Drug Administration (FDA or we) is classifying the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions into class II (special controls). The special controls that apply to the device type are identified in this… 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 March 14, 2019 Other (Public Domain) 0 reuses 0 favorites
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: 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 clinical considerations for investigational neurological devices targeting disease progression and clinical outcomes. 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 February 14, 2019 Other (Public Domain) 0 reuses 0 favorites
Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-27809. The Food and Drug Administration (FDA) is issuing a final order to reclassify the electroconvulsive therapy (ECT) device for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in… 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 December 26, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-22842. The Food and Drug Administration (FDA or we) is classifying the thermal vestibular stimulator for headache 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 19, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the External Upper Limb Tremor Stimulator From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-22695. The Food and Drug Administration (FDA or we) is classifying the external upper limb tremor stimulator 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 17, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Percutaneous Nerve Stimulator for Substance Use Disorders From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-02202. The Food and Drug Administration (FDA or we) is classifying the percutaneous nerve stimulator for substance use disorders 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… 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 February 5, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-27854. The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache 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… 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 December 27, 2017 Other (Public Domain) 0 reuses 0 favorites