Global Medtech Guidance Tracker: August 2017
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirteen new guidance documents were posted to the tracker in August.
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Electronic interface functionality, data-exchange factors and time synchronization are among key interoperability factors for device-makers to consider in device design and pre-market submissions, US FDA says in a final guidance document. The guidance stresses the need for developers to consider potential risks of interoperability from device conception and throughout the lifecycle.
Three new draft documents relating to notified bodies list the codes being prepared to determine their scope of responsibility for designation under the new EU medtech regulations and the raft of documentation they will be asked to submit when they apply for redesignation.
The digitalization of clinical trials is generating more patient safety data than companies can process. A senior EMA official says sponsors should carefully select what is needed to maintain appropriate subject oversight by “getting the science right.”