21 CFR Chapter I Subchapter H β Medical Devices β Part 864 Hematology and Pathology Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 864 Hematology and Pathology 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
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on the use of ISO 10993-1 for evaluating and testing medical devices within a risk management process. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for industry and FDA staff on using glass syringes for delivering drug and biological products. 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
Principle 7: Chemical, physical and biological properties From Therapeutic Goods Administration (TGA) π¦πΊ Principle 7 has six parts that deal with the design and construction of a medical device 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 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Supply a biological From Therapeutic Goods Administration (TGA) π¦πΊ Find information on the supply of biologicals. 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 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products From Food and Drug Administration (FDA) πΊπΈ Guidance document outlining the purpose and content of use-related risk analyses for drugs, biological products, and combination products. 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 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ A draft guidance document outlining essential drug delivery requirements for devices intended to administer drugs and biological products. 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 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Submissions received: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation From Therapeutic Goods Administration (TGA) π¦πΊ Publication of submissions to the public consultation paper Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Good Clinical Practice (GCP) Inspection Program From Therapeutic Goods Administration (TGA) π¦πΊ Clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA's Good Clinical Practice (GCP) Inspection Program. 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 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Report an adverse event or incident From Therapeutic Goods Administration (TGA) π¦πΊ Information on how to report an adverse event or drug reaction for medicines, biologicals and 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 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guide no. 63 version 2 of 16/05/2024 From Brazilian Health Regulatory Agency (Anvisa) π§π· Guide for the Biological Safety Assessment of Nanotechnology-based Materials for Use in Health. 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 May 20, 2024 Other (Public Domain) 0 reuses 0 favorites
Boundary and combination products From Therapeutic Goods Administration (TGA) π¦πΊ A guide to help sponsors figure out if their therapeutic goods are medicines, biologicals, or 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 May 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Recall action templates From Therapeutic Goods Administration (TGA) π¦πΊ Templates to help you with your communications under the Uniform recall procedure for therapeutic goods (URPTG). 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 (Non-Commercial) 0 reuses 0 favorites
Commission Implementing Decision (EU) 2024/815 of 6Β March 2024 amending Implementing Decision (EU)Β 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products From European Parliament πͺπΊ The document is a Commission Implementing Decision amending standards for medical gloves, biological evaluation of devices, sterilization, packaging, and processing of healthcare 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 March 6, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Biologicals From Therapeutic Goods Administration (TGA) π¦πΊ Find out how we define biologicals and how we regulate them. 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Reclassification of medical devices that administer medicines or biologicals by inhalation From Therapeutic Goods Administration (TGA) π¦πΊ Updated guidance to reflect new amendments made to the regulations. 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 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
General dossier requirements From Therapeutic Goods Administration (TGA) π¦πΊ Amendments to Part C to update the reference for dossier requirements for biologicals 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 October 27, 2023 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) πΊπΈ 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
Guide No. 63 version 1 of 25/07/2023 From Brazilian Health Regulatory Agency (Anvisa) π§π· Guide to Biological Safety Assessment of Nanotechnology-based Materials for Health Use Metadata quality: Metadata quality: Data description empty 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: 66.66666666666666/100 Updated on August 4, 2023 Other (Public Domain) 0 reuses 0 favorites
Biological products regulated as a therapeutic good, but not as a biological From Therapeutic Goods Administration (TGA) π¦πΊ Find out if your biological product is regulated as a different type of therapeutic good. 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 12, 2023 Other (Non-Commercial) 0 reuses 0 favorites