21 CFR Chapter I Subchapter H – Medical Devices – Part 870 Cardiovascular Devices From Food and Drug Administration (FDA) 🇺🇸 A regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 870 Cardiovascular 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CHMP/EWP/18504/2006 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
Special topic pages From Therapeutic Goods Administration (TGA) 🇦🇺 Special topic pages for advertising, including COVID-19, medicinal cannabis, nicotine vaping products and disease education. 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 862 Clinical Chemistry and Clinical Toxicology Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H - Medical Devices - Part 862 Clinical Chemistry and Clinical Toxicology 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 February 5, 2024 Other (Public Domain) 0 reuses 0 favorites
Advertising guidance for providers of disease education activities From Therapeutic Goods Administration (TGA) 🇦🇺 Complying with therapeutic goods advertising restrictions. 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 January 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance on developing drugs, biological products, and certain devices for preventing or treating graft-versus-host diseases. 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 28, 2023 Other (Public Domain) 0 reuses 0 favorites
Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency : 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 the enforcement policy for face masks and barrier face coverings during the COVID-19 pandemic. 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 September 5, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices From Ministry of Food and Drug Safety (MFDS) 🇰🇷 This guidance applies to machine Learning-enabled medical devices, in which machine learning-based AI technology is applied to diagnose, manage, or predict diseases by analyzing medical data. They also apply to AI software configured using hardware. For example, clinical decision supporting (CDS)… 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 20, 2023 Other (Public Domain) 0 reuses 0 favorites
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on transitioning medical devices within enforcement policies during the COVID-19 pandemic. 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 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19): Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for transitioning medical devices with emergency use authorizations related to COVID-19. 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 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Liver Related Disease Progression From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-00480. The Food and Drug Administration (FDA, Agency, or we) is classifying the prognostic test for assessment of liver related disease progression into class II (special controls). The special controls that apply to the device type are identified in this order and will be… 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 January 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Partial Revision of the “Points to Consider for Approval Applications for Home Medical Devices to Detect Signs of Diseases and to Encourage Medical Consultation” From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 PSEHB/MDED Notification No. 1213-4 PSEHB/PSD Notification No. 1213-3 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 December 13, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-11699. The Food and Drug Administration (FDA or we) is classifying the coronary artery disease risk indicator using acoustic heart signals 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 June 1, 2022 Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases From Food and Drug Administration (FDA) 🇺🇸 CPG Sec. 370.100 outlines guidelines for cytotoxic testing in allergic diseases. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on May 5, 2021 Other (Public Domain) 0 reuses 0 favorites
Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons and Drug-Eluting Stents to the MHRA From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The findings and recommendations of the Expert Advisory Group on paclitaxel drug-coated balloon catheters and drug-eluting stents which are used to treat patients with peripheral arterial disease. 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 18, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Guidance on the Review and Approval of Digital Therapeutics(DTx)(Revision) From Ministry of Food and Drug Safety (MFDS) 🇰🇷 This guidance shall apply to the approval/certification of the manufacturing/import, review of technical documents, and approval of clinical trial protocols for a DTx that provide evidence-based therapeutic intervention to patients for preventing, managing, or treating medical disorders or… 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 November 4, 2020 Other (Public Domain) 0 reuses 0 favorites
Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document for stakeholders and FDA staff on designing and validating NGS-based IVDs for diagnosing suspected germline diseases. 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 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-06026. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a… 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 1, 2019 Other (Public Domain) 0 reuses 0 favorites
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: 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 clinical considerations for investigational neurological devices targeting disease progression and clinical outcomes. 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 14, 2019 Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 100.300 *Non-FDA Regulated Products Involving Communicable Disease Hazards* From Food and Drug Administration (FDA) 🇺🇸 This document is a Compliance Policy Guide (CPG) titled "Non-FDA Regulated Products Involving Communicable Disease Hazards". It focuses on safety issues related to communicable diseases. 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 December 1, 2018 Other (Public Domain) 0 reuses 0 favorites