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
Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravenous Catheter Force-Activated Separation Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-18267. The Food and Drug Administration (FDA, Agency, or we) is classifying the intravenous catheter force-activated separation 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… 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 16, 2024 Other (Public Domain) 0 reuses 0 favorites
Maintenance From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses the maintenance of healthcare institutions, focusing on surveillance. 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 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Advice for health procurement teams about therapeutic goods and medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for procurement areas in hospitals, aged care residential facilities and other facilities. 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 23, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical practitioners' guide to up-classifying surgical mesh From Therapeutic Goods Administration (TGA) 🇦🇺 Surgical mesh device supply disruption guidance for doctors and hospitals. 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 December 19, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals: Overview From Health Canada 🇨🇦 Summary of guidance for hospitals about achieving compliance with federal regulatory requirement to report serious ADRs and MDIs to Health Canada. 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 18, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Progress update: Mandatory reporting of adverse events by healthcare facilities From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA is working with the Australian Commission on Safety and Quality in Health Care and Australian hospitals, peak bodies, and state, and territory governments to improve and increase rapid information sharing about medical device 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 July 12, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Serious adverse drug reactions and medical device incidents - Canada.ca From Health Canada 🇨🇦 A summary of serious adverse drug reactions and medical device incidents reported by hospitals and tracked in the Canada Vigilance database. 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 May 15, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Medical Devices; General Hospital and Personal Use Devices; Classification of the Spore Test Strip From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-03104. The Food and Drug Administration (FDA, the Agency, or we) is classifying the spore test strip 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 spore test… 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 14, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General Hospital and Personal Use Devices; Classification of the Alternate Controller Enabled Infusion Pump From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-02369. The Food and Drug Administration (FDA, Agency, or we) is classifying the alternate controller enabled infusion pump 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 4, 2022 Other (Public Domain) 0 reuses 0 favorites
Guidance on regulatory classification of point-of-use hospital water filters in the UK From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The MHRA position on the appropriate classification of point-of-use water filters for the UK market, and advice for suppliers and procurers of these products 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 October 1, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Guidance for hospital operators, healthcare professionals and other medical device users on reporting medical device incidents From Danish Medicines Agency (DKMA) 🇩🇰 A document providing guidance for hospital operators, healthcare professionals, and medical device users on reporting medical device incidents. 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 21, 2021 Other (Public Domain) 0 reuses 0 favorites
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors - Three Additional Questions: Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on reprocessing and reuse of single-use devices by third-party and hospital reprocessors, addressing three additional questions. 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
Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards From Health Canada 🇨🇦 2006 (revised 2008) Health Canada guidance document 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 September 24, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators. 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 April 28, 2020 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA From Food and Drug Administration (FDA) 🇺🇸 FDA provides labeling recommendations for reprocessed single-use devices by third parties and hospitals in this final guidance document. 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 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance on the reprocessing and reuse of single-use devices by third-party and hospital reprocessors. 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 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for the industry and FDA staff on reducing entrapment in hospital bed systems. 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 28, 2020 Other (Public Domain) 0 reuses 0 favorites
General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-09434. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify the needle destruction device, renaming the device to "sharps needle destruction device," a postamendments class III device (regulated under product code MTV), into class II… 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 4, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-27443. The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss 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 20, 2017 Other (Public Domain) 0 reuses 0 favorites