21 CFR Chapter I Subchapter H – Medical Devices – Part 876 Gastroenterology-Urology Devices From Food and Drug Administration (FDA) 🇺🇸 Regulation on Gastroenterology-Urology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 876. 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 days ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 864 Hematology and Pathology Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – 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
Private Health Insurance (Medical Devices and Human Tissue Products) Amendment (No. 2) Rules 2024 From Office of Parliamentary Council Australia 🇦🇺 Document F2024L00967. 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 Creative Commons Attribution 4.0 0 reuses 0 favorites
Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 1) 2024 From Office of Parliamentary Council Australia 🇦🇺 Document F2024L00770. 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 Creative Commons Attribution 4.0 0 reuses 0 favorites
Information on breast implant-associated anaplastic large cell lymphoma (LACL) From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last updated: June 10, 2024 Anaplastic large cell lymphoma (ALCL) associated with breast implants is a rare type of non-Hodgkin's lymphoma that affects a variety of tissues, including the breast in women with breast implants. It is currently included in a category of breast implant-associated... 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 11, 2024 Other (Public Domain) 0 reuses 0 favorites
What are 'therapeutic goods'? From Therapeutic Goods Administration (TGA) 🇦🇺 Therapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol. 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 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 878 General and Plastic Surgery Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 878 General and Plastic Surgery 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 June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Breast Implant Expert and Consumer Working Groups From Therapeutic Goods Administration (TGA) 🇦🇺 The working group aims to provide clinical advice on breast implant and tissue expander medical devices to the TGA, including advice on breast implant associated cancer. 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 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document by FDA and industry for evaluating thermal effects of medical devices that heat or cool tissues, focusing on safety and efficacy. 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 March 14, 2024 Other (Public Domain) 0 reuses 0 favorites
Advertising guidance for businesses involved with stem cells and other human cell or tissue (HCT) products 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
Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products From Therapeutic Goods Administration (TGA) 🇦🇺 The Australian Code of Good Manufacturing Practice (GMP) for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products (the Code) applies to Blood, Human Tissues and Human Cellular Therapy Products manufacturers that undertake the collection, processing, testing, storage,… 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 December 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Notification of devitalised human tissue From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇠This document is about the notification process for devitalised human tissue and its relevance to market access. 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 September 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Biomaterials and Engineering Laboratory Report: Non-active mammary implants From Therapeutic Goods Administration (TGA) 🇦🇺 Report on TGA Laboratories review of the surface of 52 different models of breast implants and tissue expanders 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 July 12, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007 From Office of Parliamentary Council Australia 🇦🇺 Document C2007A00033. 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 3, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance document titled "Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures". It falls under the topics of Clinical - Medical and Premarket. 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 May 25, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of the Carbon Dioxide Gas Controlled Tissue Expander From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-02357. The Food and Drug Administration (FDA or we) is classifying the carbon dioxide gas controlled tissue expander 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 codified language for… 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 4, 2022 Other (Public Domain) 0 reuses 0 favorites
Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-00492. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The revocation does not affect the regulations for human… 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 13, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Gastroenterology-Urology Devices; Classification of the Esophageal Tissue Characterization System From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-26200. The Food and Drug Administration (FDA or we) is classifying the esophageal tissue characterization system 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 codified language for 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 December 2, 2021 Other (Public Domain) 0 reuses 0 favorites
Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on devices used to process human cells, tissues, and cellular and tissue-based 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 May 13, 2021 Other (Public Domain) 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/610 of 14 April 2021 amending Implementing Decision (EU) 2020/437 as regards harmonised standards on medical vehicles and their equipment, anaesthetic and respiratory equipment, biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products, clinical investigation of medical devices for human subjects, non-active surgical implants, medical devices utilising animal tissues and their derivatives, electroacoustics and medical electrical equipment From European Parliament 🇪🇺 Amendment to Implementing Decision (EU) 2020/437 on harmonised standards for medical vehicles, equipment, and 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 April 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites