21 CFR Chapter I Subchapter H β Medical Devices β Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) πΊπΈ 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
Risk Assessment form From Saudi Food and Drug Authority (SFDA) πΈπ¦ Form for conducting risk assessments. 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 August 3, 2022 Other (Public Domain) 0 reuses 0 favorites
Risk-Adapted Approach to clinical trials and Risk Assessments From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK. 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 28, 2022 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment System From Food and Drug Administration (FDA) πΊπΈ Document number 2017-24159. The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified languageβ¦ 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 7, 2017 Other (Public Domain) 0 reuses 0 favorites
Reporting risks From Federal Institute for Drugs and Medical Devices (BfArM) π©πͺ Reporting risks: A document focusing on risk assessment. Metadata quality: Metadata quality: Data description empty 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: 66.66666666666666/100 Updated on November 26, 2023 Other (Public Domain) 0 reuses 0 favorites
Field corrective actions From Federal Institute for Drugs and Medical Devices (BfArM) π©πͺ Document discusses field corrective actions, with a focus on risk assessment. Metadata quality: Metadata quality: Data description empty 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: 66.66666666666666/100 Updated on November 26, 2023 Other (Public Domain) 0 reuses 0 favorites
BfArM recommendations From Federal Institute for Drugs and Medical Devices (BfArM) π©πͺ BfArM recommendations on risk assessment. Metadata quality: Metadata quality: Data description empty 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: 66.66666666666666/100 Updated on November 26, 2023 Other (Public Domain) 0 reuses 0 favorites