Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document outlining appeal options for mammography facilities regarding adverse accreditation decisions, certificate suspension/revocation, and notification orders. Administrative/procedural focus. 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
Combined studies From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Document covers various studies, focusing on clinical trials. 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 2 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Performance studies From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses performance studies, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
EU MDR Transition web publication service From Therapeutic Goods Administration (TGA) 🇦🇺 The EU MDR Transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Clinical investigations From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses clinical investigations, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Announcements From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Various announcements on clinical trials, clinical investigation etc. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Chapter 4 - nicotine dose guidance Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to test and report levels of nicotine uptake when submitting a notification of intent to market e-cigarette and vape products. 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 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 4 - nicotine dose guidance - Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to test and report levels of nicotine uptake when submitting a notification of intent to market e-cigarette and vape products in Great Britain. 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 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 2 - product type guidance - Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Which product type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain. 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 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 1.1 - submission type guidance Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Northern Ireland. 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 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 1 - submission type guidance - Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain. 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 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical devices - Vigilance notification From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Medical devices - Vigilance notification in your application process 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 August 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: 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 premarket notification submissions for metal expandable biliary stents. 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
Notification of Post Market clinical investigation with additional invasive or burdensome procedures From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 August 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Notification of initiation of clinical investigations Post Market From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 August 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Dental Curing Lights - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document for industry and FDA staff on premarket notification (510(k)) submissions for dental curing lights. 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 July 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A draft guidance document for industry and FDA staff on premarket notification (510(k)) submissions for dental composite resin devices. 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 July 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical devices - Clinical investigations vigilance From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Medical devices - Vigilance of clinical investigations 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 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
In vitro diagnostic medical devices - Performance studies vigilance From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure In vitro diagnostic medical devices - Vigilance of performance studies 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 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Online assessment tool and online notification form From Therapeutic Goods Administration (TGA) 🇦🇺 Use our online assessment tool and notification form to transition to the new EU MDR, so you can continue supplying 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 June 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites