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
21 CFR Chapter I Subchapter H – Medical Devices – Part 880 General Hospital and Personal Use Devices From Food and Drug Administration (FDA) 🇺🇸 21 CFR Chapter I Subchapter H - Medical Devices - Part 880 General Hospital and Personal Use Devices. 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 August 19, 2024 Other (Public Domain) 0 reuses 0 favorites
GHTF Study Group 2 - Post-market Surveillance/Vigilance From International Medical Device Regulators Forum (IMDRF) 🌍 GHTF Study Group 2 - Post-market Surveillance/Vigilance documents 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 July 27, 2012 Other (Public Domain) 0 reuses 0 favorites
Guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMEA/273974/2005. 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 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Notification of a change in sponsorship From Therapeutic Goods Administration (TGA) 🇦🇺 Change of sponsor name forms are now available 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 14, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ZL404_00_001e_WL Guidance documentTransfer of marketing authorisation From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Guidance document on transferring marketing authorisation. 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 May 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Changes affecting TGA-issued conformity assessment certificates From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for notifying the TGA about ‘substantial changes’ to, or transfers of, conformity assessment certificates. 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 August 19, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Changing the sponsor of therapeutic goods From Therapeutic Goods Administration (TGA) 🇦🇺 If sponsorship is transferred to you, you need to notify the TGA 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 8, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors From Food and Drug Administration (FDA) 🇺🇸 Guidance document on transferring clinical investigation oversight to another IRB, providing considerations for IRBs, investigators, and sponsors. 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 7, 2020 Other (Public Domain) 0 reuses 0 favorites
Provision No. 9688/2019 From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷 Registration, modifications, revalidation, transfer and cancellation of Class I, II, III and IV Medical Products, national and imported. B.O. December 02, 2019. 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 1, 2019 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on content of the certificates, voluntary certificate transfers From European Commission 🇪🇺 Guidance on content of certificates and voluntary transfers, focusing on notified bodies. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-10563. The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory… 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 17, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel; Request for Comments From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-25781. The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA intends to limit the proposed exemption to single-use,… 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 30, 2017 Other (Public Domain) 0 reuses 0 favorites
Transfers of conformity assessment certificates From Therapeutic Goods Administration (TGA) 🇦🇺 Transfers of conformity assessment certificates 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 29, 2017 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-04897. The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for powered patient transport devices commonly known as stairway chair lifts. These devices are used to assist in the transfer… 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 4, 2013 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Medical Device Data Systems From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-3321. The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one… 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 15, 2011 Other (Public Domain) 0 reuses 0 favorites