21 CFR Chapter I Subchapter H – Medical Devices – Part 880 General Hospital and Personal Use Devices From Food and Drug Administration (FDA) 🇺🇸 21 CFR Chapter I Subchapter H - Medical Devices - Part 880 General Hospital and Personal Use Devices. Regulation. 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 August 19, 2024 Other (Public Domain) 0 reuses 0 favorites
Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for industry and stakeholders on emergency use authorization of medical products and related authorities. 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 August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 868 Anesthesiology Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 868 Anesthesiology 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 May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for laboratory manufacturers and FDA staff on enforcement policy for certain in vitro diagnostic devices during public health emergencies without a Section 564 declaration. Focuses on outbreak response. 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 April 29, 2024 Other (Public Domain) 0 reuses 0 favorites
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document discussing enforcement policies for tests during a Section 564 declared emergency, aimed at industry and FDA staff. Focuses on outbreak-related topics. 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 April 29, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 812 Investigational Device Exemptions From Food and Drug Administration (FDA) 🇺🇸 Regulation on Investigational Device Exemptions under 21 CFR Chapter I Subchapter H - Medical Devices - Part 812. 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 23, 2024 Other (Public Domain) 0 reuses 0 favorites
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for the 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review by the FDA. 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 December 20, 2023 Other (Public Domain) 0 reuses 0 favorites
Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on the enforcement policy for face masks and barrier face coverings during the COVID-19 pandemic. 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 September 5, 2023 Other (Public Domain) 0 reuses 0 favorites
Post-market review of face masks: Overview From Therapeutic Goods Administration (TGA) 🇦🇺 Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 ceased on 31 January 2021. 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 31, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Meeting of the Executive Steering Group on Shortages of Medical Devices (MDSSG) From European Medicines Agency (EMA) 🇪🇺 Meeting of the Executive Steering Group on Shortages of Medical Devices (MDSSG). Metadata quality: Metadata quality: Data description empty Files documented 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 July 25, 2023 Other (Public Domain) 0 reuses 0 favorites
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on transitioning medical devices within enforcement policies during the COVID-19 pandemic. 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 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19): Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for transitioning medical devices with emergency use authorizations related to COVID-19. 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 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Notice on Proposed changes to the Medical Devices Regulations to address future public health emergencies From Health Canada 🇨🇦 Notice on Health Canada's proposed regulatory amendments to expand the Medical Devices Regulations beyond COVID-19 medical devices. 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 23, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
A new role for EMA in monitoring and mitigating critical medical device shortages during public health emergencies From European Medicines Agency (EMA) 🇪🇺 EMA takes on new role in managing medical device shortages during public health crises. 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Policy for Monkeypox Tests to Address the Public Health Emergency: Guidance for Laboratories, Commercial Manufacturers and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for laboratories, manufacturers, and FDA staff on monkeypox tests during a public health emergency. 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 September 13, 2022 Other (Public Domain) 0 reuses 0 favorites
Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use From Food and Drug Administration (FDA) 🇺🇸 A guidance document titled "Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use" focusing on premarket topics. 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 April 27, 2021 Other (Public Domain) 0 reuses 0 favorites
Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on exceptions to informed consent requirements for emergency research, focusing on Good Clinical Practice (GCP). 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 April 21, 2020 Other (Public Domain) 0 reuses 0 favorites
Radiation Biodosimetry Medical Countermeasure Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for the development and use of medical devices for radiation biodosimetry in emergencies. 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 14, 2019 Other (Public Domain) 0 reuses 0 favorites
Commission Delegated Directive 2014/13/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators Text with EEA relevance From European Parliament 🇪🇺 Commission Delegated Directive 2014/13/EU amends Annex IV to Directive 2011/65/EU regarding lead exemption in medical devices. 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 18, 2013 Creative Commons Attribution 4.0 0 reuses 0 favorites
Temporary Pacemaker Electrodes Recall From National Organization for Medicines (EOF) 🇬🇷 The EOF informs you that Johnson & Johnson International/ETHICON has issued an Emergency Voluntary Recall of multiple batches of Pacemaker Wires with ... 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 30, 2012 Other (Public Domain) 0 reuses 0 favorites