21 CFR Chapter I Subchapter H β Medical Devices β Part 801 Labeling From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 801 Labeling". 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
Medical devices regulations: compliance and enforcement From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Information on MHRA's enforcement duties and how to report a non-compliant 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 May 17, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical Devices; Laboratory Developed Tests From Food and Drug Administration (FDA) πΊπΈ Document number 2024-08935. The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory.β¦ 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 6, 2024 Other (Public Domain) 0 reuses 0 favorites
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance document for laboratory manufacturers and FDA staff on enforcement policy for certain in vitro diagnostic devices during public health emergencies without a Section 564 declaration. Focuses on outbreak response. 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 April 29, 2024 Other (Public Domain) 0 reuses 0 favorites
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance document discussing enforcement policies for tests during a Section 564 declared emergency, aimed at industry and FDA staff. Focuses on outbreak-related topics. 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 April 29, 2024 Other (Public Domain) 0 reuses 0 favorites
Enforcement Rule of the Medical Devices Act From Ministry of Food and Drug Safety (MFDS) π°π· ENFORCEMENT RULE OF THE MEDICAL DEVICES ACT_Ordinance of the Prime Minister No.1819_20220721 μλ£κΈ°κΈ°λ² μνκ·μΉ(2022.7.21.) Note: MFDS offers the English version as a service to an international audience. Any discrepancies or differences created in the translation are not binding and have no legal effec... 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 19, 2024 Other (Public Domain) 0 reuses 0 favorites
Enforcement Rule of the Act on In-Vitro Diagnostic Medical Devices From Ministry of Food and Drug Safety (MFDS) π°π· ENFORCEMENT RULE OF THE ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES(20201231) 체μΈμ§λ¨μλ£κΈ°κΈ°λ² μνκ·μΉ(20201231) Note: MFDS offers the English version as a service to an international audience. Any discrepancies or differences created in the translation are not binding and have no legal effect for complian... 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 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Enforcement Policy for Clinical Electronic Thermometers: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on the enforcement policy for clinical electronic thermometers. 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 November 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on the enforcement policy for certain supplements for premarket approval submissions. 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 November 1, 2023 Other (Public Domain) 0 reuses 0 favorites
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring". It provides guidance for industry and FDA staff on labeling and premarket requirements. 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 October 18, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Laboratory Developed Tests From Food and Drug Administration (FDA) πΊπΈ Document number 2023-21662. The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD isβ¦ 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 October 3, 2023 Other (Public Domain) 0 reuses 0 favorites
Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on the enforcement policy for face masks and barrier face coverings during the COVID-19 pandemic. 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 September 5, 2023 Other (Public Domain) 0 reuses 0 favorites
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on transitioning medical devices within enforcement policies during the COVID-19 pandemic. 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 March 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Off-label advertising and sale of COVID-19 rapid antigen tests under workplace screening initiative: Interim enforcement approach From Health Canada π¨π¦ Medical Devices Establishment License bulletin outlining the interim enforcement approach to off-label advertising and sale of rapid antigen tests under workplace screening 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 April 12, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Distribution of rapid antigen tests under the workplace screening initiative: Interim enforcement approach From Health Canada π¨π¦ Information for importing and distributing COVID-19 rapid antigen tests as part of the COVID-19 workplace screening initiative 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 14, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Advertising enforcement and outcomes From Therapeutic Goods Administration (TGA) π¦πΊ There are sanctions and penalties for advertising that does not comply with 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 November 15, 2021 Other (Non-Commercial) 0 reuses 0 favorites
The Medicines and Medical Devices Act 2021 (Commencement No. 1 and Transitional and Savings Provision) Regulations 2021 From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ These Regulations commence certain provisions of the Medicines and Medical Devices Act 2021 (βthe Actβ) on 26th May 2021. Regulation 2 brings the whole of Chapter 3 of Part 4 of the Act (enforcement), apart from section 31 (civil sanctions), into force, along with sections 39 and 40 (disclosure ofβ¦ 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 24, 2021 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Medicines and Medical Devices Act 2021 From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ An Act to make provision about a Commissioner for Patient Safety in relation to human medicines and medical devices; confer power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices; make provision about the enforcement of regulations, and theβ¦ 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 11, 2021 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) : From Food and Drug Administration (FDA) πΊπΈ This is a guidance document for manufacturers and assemblers of diagnostic X-ray systems regarding the enforcement policy for positive-beam limitation requirements. 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 March 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for industry and FDA staff on factors to consider in medical device availability, compliance, and enforcement decisions. 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 March 4, 2019 Other (Public Domain) 0 reuses 0 favorites