US FDA Lays Out Post-COVID EUA Transition Plans for Medical Devices
US FDA publishes new guidance on timelines and related requirements for emergency use authorization (EUA) terminations for medical devices and IVDs following COVID-19 emergency resolution. Learn more at Emergo by UL.
US FDA Maps Out Medical Device Regulatory Guidance Planned for 2022
FDA center for devices and radiological health (CDRH) plans to publish guidance covering SaMD, postmarket surveillance, emergency use authorization (EUA) transitions, and more.
US FDA Rolls Out Final Guidance on Unique Device Identifier (UDI) Labeling Requirements
Final FDA guidance on Unique Device Identifier (UDI) rules for medical devices and stand-alone software comes several years after draft guidance issued. Learn more at Emergo by UL.
6 Key Principles of GDPR
General principles of GDPR and actions manufacturers can take to gain or maintain compliance.
HIPAA Regulations
Secure data management to meet HIPAA, PHI, and requirements of Covered Entities or Business Associates.
HIPAA and GDPR Overview
Secure data management to meet HIPAA and GDPR requirements and achieve regulatory compliance.
Taiwan Medical Device Regulations
This chart shows Taiwan's medical device regulatory approval process and can be downloaded from the Regulatory Affairs Management Suite (RAMS) for free.
India Medical Device Regulations and Approval
This chart illustrates the CDSCO medical device approval process in India and is free to download in the Regulatory Affairs Management Suite (RAMS).
European In Vitro Diagnostic Devices Regulation (IVDR) CE Marking Regulatory Process
This process chart illustrates the CE marking certification process per IVD device classification and is available for download in the Regulatory Affairs Management Suite (RAMS).
Comprehensive Guide to FDA Clearance for Your Medical and IVD Device
Learn how to get FDA clearance for your medical device and navigate the approval process smoothly with our 510(k) flowchart.