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
Commission Delegated Directive (EU) 2020/366 of 17 December 2019 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases (Text with EEA relevance) From European Parliament 🇪🇺 Commission Delegated Directive (EU) 2020/366 amends Annex IV to Directive 2011/65/EU, allowing lead exemption in certain 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 December 17, 2019 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases From European Parliament 🇪🇺 This document is a draft delegated directive that aims to amend the use of lead in certain medical devices for blood and body fluid analysis. 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 17, 2019 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases From European Parliament 🇪🇺 This document is a draft delegated directive that aims to amend the use of lead in certain medical devices for blood and body fluid analysis. 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 30, 2019 Creative Commons Attribution 4.0 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-10563. The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory… 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 May 17, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel; Request for Comments From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-25781. The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA intends to limit the proposed exemption to single-use,… 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 November 30, 2017 Other (Public Domain) 0 reuses 0 favorites