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Tariffs Again in Play as Trade Tensions Mount
Feb 28, 2025
The global trade picture for medical devices has become more complicated in the first weeks of 2025 ...
Impact of Federal Funding Freeze on Clinical Trials and Patient Safety
Feb 25, 2025
In January 2025, the Trump administration implemented a temporary freeze on federal financial assist...
FDA Continues Working to Prevent Device Shortages
Feb 06, 2025
The FDA’s Center for Devices and Radiological Health (CDRH) has limited authority to require that de...
FDA To Seek Expanded Authority for Device Shortage Reporting
Jan 29, 2025
The COVID-19 pandemic amplified the FDA’s focus on medical device shortages, but medical device comp...
FDA Stands Its Ground on CDS Guidance
Jan 08, 2025
The FDA’s guidance for clinical decision support (CDS) programs has proven unusually controversial, ...
FDA Finalizes Guidance for AI Predetermined Change Control Plans
Dec 26, 2024
The FDA has published the final version of a guidance for predetermined change control plans (PCCPs)...
FDA Appoints New Director for Center for Devices
Nov 12, 2024
The FDA has appointed a new director for the Center for Devices and Radiological Health (CDRH) to re...