21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of 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 March 18, 2024 Other (Public Domain) 0 reuses 0 favorites
Communication on the European Commission's survey on monitoring the availability of Medical Devices (MD) on the European Union market From National Organization for Medicines (EOF) 🇬🇷 To see the announcement, click 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 6, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical devices reforms: Low risk products - Class 1 medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Appropriate regulation of low risk devices improves their availability. 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 June 27, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices reforms: Low risk products - other therapeutic goods From Therapeutic Goods Administration (TGA) 🇦🇺 Appropriate regulation of low risk devices improves their availability. 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 13, 2023 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 821 Medical Device Tracking Requirements From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "Medical Device Tracking Requirements" under 21 CFR Chapter I Subchapter H. 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 March 31, 2023 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 806 Medical Devices; Reports of Corrections and Removals From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "Medical Devices; Reports of Corrections and Removals" under 21 CFR Chapter I Subchapter H. 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 March 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Report production, external review, and public consultation From Ministry of Health (Italy) (MDS) 🇮🇹 Reports related to assessments identified as a priority can be entrusted either to AGENAS, which has been producing HTA reports on behalf of the Ministry of Health since 2007, or to Collaborating Centers registered in a National Register based on the possession of specific requirements. The type… 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 21, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs From European Commission 🇪🇺 This document discusses the transition to the MDR and IVDR, focusing on notified body capacity and availability of medical devices and IVDs. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
MDR Newsletter 8/2021: New medical video library available From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter for August 2021 announcing the availability of a new medical video library. 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 March 2, 2022 Other (Public Domain) 0 reuses 0 favorites
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for industry and FDA staff on preparing notices for investigational medical devices and recruiting study subjects. 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
Public Availability of Advisory Committee Members' Financial Interest Information and Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on the public availability of financial interest information and waivers for FDA advisory committee members. 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 20, 2019 Other (Public Domain) 0 reuses 0 favorites
Preparation and Public Availability of Information Given to Advisory Committee Members: Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance to the industry on preparing and sharing information with advisory committee members. 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 20, 2019 Other (Public Domain) 0 reuses 0 favorites
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: 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 factors to consider in medical device availability, compliance, and enforcement decisions. 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 4, 2019 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-12088. The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Bacillus species (spp). detection into class II (special controls), in accordance with the recommendation of the Microbiology Devices Advisory Panel (the Panel). In addition,… 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 18, 2011 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-9899. The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than… 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 25, 2011 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser System for Aesthetic Use From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-8944. The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is entitled "Class II Special Controls Guidance Document: Low Level Laser System 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 April 14, 2011 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-6620. The Food and Drug Administration (FDA) is classifying the ovarian adnexal mass assessment score test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled "Guidance for Industry and FDA Staff;… 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, 2011 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System for Aesthetic Use From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-2552. The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special… 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 7, 2011 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy From Food and Drug Administration (FDA) 🇺🇸 Document number 2010-28873. The Food and Drug Administration (FDA) is classifying the non- powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II (special controls). The special control that will apply to the device is the guidance document entitled… 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 17, 2010 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With Adjunct Wound Closure Device Intended for Topical Approximation of Skin From Food and Drug Administration (FDA) 🇺🇸 Document number 2010-28356. The Food and Drug Administration (FDA) is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance… 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 10, 2010 Other (Public Domain) 0 reuses 0 favorites