21 CFR Chapter I Subchapter H β Medical Devices β Part 870 Cardiovascular Devices From Food and Drug Administration (FDA) πΊπΈ A regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 870 Cardiovascular 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
Conducting Remote Regulatory Assessments Questions and Answers: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Draft guidance document providing questions and answers on conducting remote regulatory assessments for various topics including adverse event reporting, compliance, and pharmaceutical quality. 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
21 CFR Chapter I Subchapter H β Medical Devices β Part 880 General Hospital and Personal Use Devices From Food and Drug Administration (FDA) πΊπΈ 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
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
Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ PMDA/CPE Notification No. 325 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 July 3, 2023 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 892 Radiology Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 892 Radiology 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 June 7, 2023 Other (Public Domain) 0 reuses 0 favorites
Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ PMDA/CPE Notification No. 0525001 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 25, 2022 Other (Public Domain) 0 reuses 0 favorites
Webinar presentation: Remote GMP inspections: Current feedback and future considerations From Therapeutic Goods Administration (TGA) π¦πΊ A webinar presentation discussing remote GMP inspections, including current feedback and future considerations. Focuses on manufacturing. 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 18, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Procedure for Remote Inspection as a part of compliance inspection on drugs and regenerative medical products From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ PMDA/CPE Notification No. 1116002 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 16, 2020 Other (Public Domain) 0 reuses 0 favorites
Remote Interlock Connectors (Laser Notice 11) From Food and Drug Administration (FDA) πΊπΈ A guidance document titled "Remote Interlock Connectors (Laser Notice 11)" for laser safety. 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 on March 16, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Steerable Cardiac Ablation Catheter Remote Control System From Food and Drug Administration (FDA) πΊπΈ Document number 2015-24624. The Food and Drug Administration (FDA) is classifying the steerable cardiac ablation catheter remote control system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codifiedβ¦ 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 September 30, 2015 Other (Public Domain) 0 reuses 0 favorites