21 CFR Chapter I Subchapter H โ Medical Devices โ Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) ๐บ๐ธ 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
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 876 Gastroenterology-Urology Devices From Food and Drug Administration (FDA) ๐บ๐ธ 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 โ Medical Devices โ Part 864 Hematology and Pathology Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ 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
Information on breast implant-associated anaplastic large cell lymphoma (LACL) From Spanish Agency for Medicines and Medical Devices (AEMPS) ๐ช๐ธ 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
Breast implants and anaplastic large cell lymphoma (ALCL) From Ministry of Health (Italy) (MDS) ๐ฎ๐น Medical devices - Breast implants and anaplastic large cell lymphoma (ALCL) 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 17, 2024 Creative Commons Attribution 3.0 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) ๐ฆ๐บ 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
Therapeutic goods and use of human embryos or human embryonic stem cells or material derived therefrom From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Find out what process to follow if a product is manufactured using a human embryo or a human embryonic stem cell, or any material sourced from such an embryo or stem cell. 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 19, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices; Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2023-24717. The Food and Drug Administration (FDA, Agency, or we) is classifying the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions into class II (special controls). The special controls that apply to the device type areโฆ 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 9, 2023 Other (Public Domain) 0 reuses 0 favorites
Breast implant associated cancer: health professionals information From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Information about breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) for health professionals. 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 19, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Squamous cell carcinoma (SCC) and different types of lymphomas occurring in the capsule around breast implants From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Information for healthcare professionals, patients, and the public. 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 7, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guide for manufacturers in the development of Technical Master Files relevant to blood, blood components and haematopoietic progenitor cells. 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 25, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Information for patients, public and health care professionals. 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 28, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater From Food and Drug Administration (FDA) ๐บ๐ธ 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 humanโฆ 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
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) ๐บ๐ธ 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
Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2020-27828. The Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The proposed revocation does not affect the regulations for human cells,โฆ 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, 2020 Other (Public Domain) 0 reuses 0 favorites
Regulation of stem cell treatments: information for practitioners From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Introduction to the regulatory requirements for practitioners that provide stem cell treatments. 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 May 19, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The TGA thanks respondents who provided a submission in response to the public consultation paper 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 February 24, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Excluded autologous human cells and tissues From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Minor amendments to exclusion criteria of autologous HCT products 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 September 11, 2019 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification: Class II Devices; Flow Cytometer Instruments; Request for Comments From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2019-03967. The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to conditions and limitations. The Agency has determined based on established factors that theseโฆ 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, 2019 Other (Public Domain) 0 reuses 0 favorites
Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System (PDF version) From Food and Drug Administration (FDA) ๐บ๐ธ This document is a special controls guidance on immunomagnetic circulating cancer cell selection and enumeration system for 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 December 1, 2018 Other (Public Domain) 0 reuses 0 favorites