1. Medtech Insight

Planning Board Proposes Postmarket Device Surveillance Timeline

A planning board created to develop a framework for a new U.S. medical device surveillance system has proposed a seven year plan on how to get the system up and running, which will include creating incentive systems for stakeholders as well as reducing the burden of recording and managing device data.

FDA and its collaborators should move quickly in the next year or two to start an incubator project with fact-finding activities and pilot programs to help launch a national postmarket surveillance system that builds on unique device identifiers (UDIs), registries and innovative data capture and analysis strategies, a multi-stakeholder planning board recommends.

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