Card News From Ministry of Food and Drug Safety (MFDS) π°π· Medical device policy news β cards. Metadata quality: Metadata quality: Data description empty Files documentation missing 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: 66.66666666666666/100 Updated today Other (Public Domain) 0 reuses 0 favorites
MHRA Strategy for Improving Safety Communications From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The MHRAβs strategy for Improving Safety Communications for 2024 to 2027. 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 2 days ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
CPG Sec 390.100 Definition of βCommerceβ - 21 CFR 1000.3(d) 2 From Food and Drug Administration (FDA) πΊπΈ A Compliance Policy Guide outlining the definition of "Commerce" as per 21 CFR 1000.3(d) 2. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Compliance Policy Guides Index From Food and Drug Administration (FDA) πΊπΈ A document outlining an index of Compliance Policy Guides (CPG) for regulatory compliance purposes. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11 From Food and Drug Administration (FDA) πΊπΈ A document outlining the process for the Secretary to determine non-compliance or defects in products, referencing 21 CFR 1003.11. Part of Compliance Policy Guide (CPG). 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 160.100 Regulatory Actions and Small Business From Food and Drug Administration (FDA) πΊπΈ CPG Sec. 160.100 provides guidance on regulatory actions and their impact on small businesses. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 110.100 Certification for Exports (Withdrawn 11/04/2021) From Food and Drug Administration (FDA) πΊπΈ This document is a Compliance Policy Guide (CPG) titled "CPG Sec. 110.100 Certification for Exports (Withdrawn 11/04/2021)". 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Implementation of medical devices future regime From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition. 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 3, 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
Impact of AI on the regulation of medical products From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Implementing the Artificial Intelligence (AI) White Paper principles. 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 30, 2024 Open Government Licence 2.0 (United Kingdom) 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
Guidance on Saudi Food and Drug Authority Policy for Engagement with Patients (MDS-G019) From Saudi Food and Drug Authority (SFDA) πΈπ¦ Guidance providing instructions on patient engagement policy. 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 November 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance on Saudi Food and Drug Authority Policy for Engagement with Healthcare Practitioners (MDS-G017) From Saudi Food and Drug Authority (SFDA) πΈπ¦ Guidance on engaging with healthcare practitioners in Saudi Arabia. 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 November 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance on Saudi Food and Drug Authority Policy for Collection of Patient Experience Data (MDS-G018) From Saudi Food and Drug Authority (SFDA) πΈπ¦ Guidance on collection of patient experience data. 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 November 30, 2023 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
CPG Sec 100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients From Food and Drug Administration (FDA) πΊπΈ This document is a Compliance Policy Guide (CPG) titled "CPG Sec 100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients". 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 October 3, 2023 Other (Public Domain) 0 reuses 0 favorites