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The recent International Medical Device Regulators Forum (IMDRF) meeting in Beijing featured presentations by international regulatory authorities on their significant regulatory changes. Read More
A new draft Brexit agreement announced last week would provide an almost two-year transition period whereby U.K. and European device companies will continue as they have under EU rules. Read More
Most IMDRF regions have developed programs for consensus standards, setting the stage for future harmonization, the Standards Working Group said. Read More
Class III and IV medical devices produced using additive manufacturing “require a review of submitted evidence of safety and effectiveness before a license can be issued,” the agency said. Read More
The FDA disagreed with OIG’s conclusions that the lack of a formal arrangement with federal partners hurts information flow about cybersecurity. Read More
The FDA granted an emergency use authorization (EUA) for a single-use, rapid fingerstick test for the Ebola virus, only the second test of its kind made available under an EUA. Read More
The International Medical Device Regulators Forum (IMDRF) has released final guidances on optimizing standards for regulatory use, essential principles of safety and performance, and definitions for personalized devices. Read More