Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for manufacturers of in vitro diagnostic devices on Clinical Laboratory Improvement Amendments (CLIA) waiver applications. 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
Requesting a waiver for a medical device without CE marking From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Requesting a waiver for a medical device without CE marking 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 822 Postmarket Surveillance From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 822 Postmarket Surveillance". 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 – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of 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 March 18, 2024 Other (Public Domain) 0 reuses 0 favorites
Reformatting Product Information: Frequently asked questions From Therapeutic Goods Administration (TGA) 🇦🇺 Update about the transitionary arrangements for reformatting product information, including accessing a fee waiver 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 812 Investigational Device Exemptions From Food and Drug Administration (FDA) 🇺🇸 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
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-27935. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a… 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 (Public Domain) 0 reuses 0 favorites
MHRA fees From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Fees payable to the MHRA for 2023 to 2024 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 November 20, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
ACE scheme waiver guidance From Therapeutic Goods Administration (TGA) 🇦🇺 Information about the Annual Charge Exemption scheme waiver process 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 24, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance document titled "Recommendations for Dual 510(k) and CLIA Waiver by Application Studies" for industry and FDA staff. It covers topics related to postmarket 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 January 26, 2021 Other (Public Domain) 0 reuses 0 favorites
Public Availability of Advisory Committee Members' Financial Interest Information and Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on the public availability of financial interest information and waivers for FDA advisory committee members. 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 20, 2019 Other (Public Domain) 0 reuses 0 favorites
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-24822. The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This proposed rule, if finalized, would allow an exception from the requirement to obtain informed consent when a… 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 15, 2018 Other (Public Domain) 0 reuses 0 favorites
Application for Waiver from Written Confirmation Requirement From Health Products Regulatory Authority (HPRA) 🇮🇪 A form for requesting a waiver from the written confirmation requirement. 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 June 9, 2014 Other (Public Domain) 0 reuses 0 favorites
Annual Charge Waiver or Refund for ARTG Entries Subject to Reclassification From Therapeutic Goods Administration (TGA) 🇦🇺 Closes 30 Jun 2029 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 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites