21 CFR Chapter I Subchapter H – Medical Devices – Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) 🇺🇸 Regulation on Immunology and Microbiology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 866. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 88.88888888888889/100 Updated 1 day ago Other (Public Domain) 0 reuses 0 favorites
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for manufacturers of in vitro diagnostic devices on Clinical Laboratory Improvement Amendments (CLIA) waiver applications. 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
Common specification requirements for in vitro diagnostic devices From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD 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 May 21, 2024 Open Government Licence 2.0 (United Kingdom) 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In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for laboratory manufacturers and FDA staff on enforcement policy for certain in vitro diagnostic devices during public health emergencies without a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
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document on evaluating performance characteristics of in vitro diagnostic devices for detecting and differentiating influenza viruses. 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 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on informed consent for studies using leftover human specimens, aimed at sponsors, IRBs, and FDA staff. 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 22, 2024 Other (Public Domain) 0 reuses 0 favorites
The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“Regulation… 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 22, 2024 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Unique device identification system From Ministry of Health (Italy) (MDS) 🇮🇹 The unique device identification system ("UDI system") provided for in the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Devices (IVD) Regulation (EU) 2017/746 allows for the identification and facilitates the traceability of devices. The system involves: assigning a basic… 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 12, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) From European Commission 🇪🇺 This document provides guidance on the role of a 'person responsible for regulatory compliance' in medical device and in vitro diagnostic device regulations. 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 Creative Commons Attribution 4.0 0 reuses 0 favorites
Usage information flow From Ministry of Health (Italy) (MDS) 🇮🇹 The Decree of the Minister of Health June 11, 2010, provided for the establishment of the database for monitoring medical devices that healthcare facilities directly managed by the National Health Service purchase or make available for use. The database is fed by individual regions and also covers… 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 13, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
MDR/IVDR Newsletter 10/2022: Basics about IVD devices in the light of the IVDR or what devices I need to register as an IVD distributor From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing the basics of in vitro diagnostic (IVD) devices under the In Vitro Diagnostic Regulation (IVDR) and registration requirements for IVD distributors. 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 29, 2023 Other (Public Domain) 0 reuses 0 favorites
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for the industry and FDA staff regarding the replacement reagent and instrument family policy for in vitro diagnostic devices. 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 16, 2022 Other (Public Domain) 0 reuses 0 favorites
Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) From European Commission 🇪🇺 Application form for conformity assessment bodies seeking designation as notified bodies under the IVDR. 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
Testing for Biotin Interference in In Vitro Diagnostic Devices: Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Guidance document on testing for biotin interference in in vitro diagnostic devices, providing industry guidance. 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 June 11, 2021 Other (Public Domain) 0 reuses 0 favorites
Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devices From Health Canada 🇨🇦 Cover letter of a 1999 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 March 19, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs) From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Document Number MD027 - Version 1 Metadata quality: Metadata quality: Data description empty 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: 44.44444444444444/100 Updated on March 12, 2021 Other (Public Domain) 0 reuses 0 favorites
Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19 From Ministry of Food and Drug Safety (MFDS) 🇰🇷 Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19 Metadata quality: Metadata quality: Data description empty 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: 44.44444444444444/100 Updated on November 4, 2020 Other (Public Domain) 0 reuses 0 favorites
Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 From Food and Drug Administration (FDA) 🇺🇸 A guidance document outlining review criteria for premarket approval of in vitro diagnostic devices for detecting antibodies to Parvovirus B19. 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 17, 2020 Other (Public Domain) 0 reuses 0 favorites
In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document providing answers to frequently asked questions about in vitro diagnostic device studies for industry and FDA staff. 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
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on establishing the performance characteristics of in vitro diagnostic devices for detecting antibodies to Borrelia burgdorferi. 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