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According to AdvaMed, an online medical device labeling database poses numerous problems, “including risk to patient safety due to the frequency at which patient labeling may be updated.” Read More
Research coordinators should track adverse events that come up during a device trial and build a database around simple “yes/no” propositions. Read More
The entities would apply for the appropriate conformity assessment procedure and provide UDI-product registration, the Commission said in five newly released guidances that provide clarification on UDI provisions. Read More
The IMDRF’s Standards Working Group issued final guidance on optimizing standards for regulatory use, noting that optimized standards offer a way to streamline regulatory processes as medical devices grow in complexity and international markets expand. Read More
The FDA issued a final order reclassifying the active implantable bone conduction hearing system as a Class II device with certain special controls. Read More
Australia’s Therapeutic Goods Administration outlines a proposed new regulatory framework for in vitro diagnostic devices in a new consultation paper. Read More