Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on non-clinical engineering tests and labeling for intravascular stents and delivery 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 August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 809 In Vitro Diagnostic Products for Human Use From Food and Drug Administration (FDA) πΊπΈ Regulation on in vitro diagnostic products for human use under 21 CFR Chapter I Subchapter H - Medical Devices - Part 809. 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 July 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Understand medical device labelling requirements From Therapeutic Goods Administration (TGA) π¦πΊ Information for manufacturers and sponsors on meeting medical device labelling requirements. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 820 Quality System Regulation From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 820 Quality System 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 June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 801 Labeling From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 801 Labeling". 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 June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document focusing on labeling requirements for the remanufacturing of medical devices, aimed at industry entities 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 not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Principles of Labelling for Medical Devices and IVD Medical Devices From International Medical Device Regulators Forum (IMDRF) π Technical document: IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2) Metadata quality: Metadata quality: Data description empty Files documented 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 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations From Health Canada π¨π¦ 2006 Health Canada guidance document providing guidance for medical devices manufacturers on the use of standards in demonstrating compliance with the Safety and Effectiveness Requirements and Labelling Requirements of the Canadian Medical Devices Regulations 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 15, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document for preparing IDEs for spinal systems, providing labeling guidance for industry and/or 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 April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies" for the industry and FDA staff. It covers topics such as clinical studies, good clinical practice, labeling, and premarket evaluation. 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 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical devices Unique Device Identification (UDI) From Therapeutic Goods Administration (TGA) π¦πΊ Labelling and packaging information about medical devices Unique Device Identification (UDI). 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 2, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior From Food and Drug Administration (FDA) πΊπΈ Document number 2024-06037. The Food and Drug Administration (FDA, the Agency, or we) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA has determined these devices present an unreasonable and substantial risk ofβ¦ 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 26, 2024 Other (Public Domain) 0 reuses 0 favorites
UDI labelling for sponsors and manufacturers From Therapeutic Goods Administration (TGA) π¦πΊ Understand and apply the UDI labelling and packaging requirements to your medical devices. 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 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical device labelling obligations From Therapeutic Goods Administration (TGA) π¦πΊ This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations. 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 812 Investigational Device Exemptions From Food and Drug Administration (FDA) πΊπΈ Regulation on Investigational Device Exemptions under 21 CFR Chapter I Subchapter H - Medical Devices - Part 812. 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 January 23, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical devices labelling and information From Therapeutic Goods Administration (TGA) π¦πΊ Labelling and other information provided with medical devices. 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 2, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Labelling and packaging From Therapeutic Goods Administration (TGA) π¦πΊ Regulatory information on the labelling and packaging of medicines and medical devices 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 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 830 of 06/12/2023 From Brazilian Health Regulatory Agency (Anvisa) π§π· Provides for risk classification, notification and registration regimes, labeling requirements and instructions for use for in vitro diagnostic medical devices, including their instruments. Metadata quality: Metadata quality: Data description filled Files documented 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: 66.66666666666666/100 Updated on December 11, 2023 Other (Public Domain) 0 reuses 0 favorites
Ensuring compliance after removing the product information insert From Therapeutic Goods Administration (TGA) π¦πΊ This guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order. 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 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring". It provides guidance for industry and FDA staff on labeling and premarket requirements. 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 18, 2023 Other (Public Domain) 0 reuses 0 favorites