The original plan, called “Strengthening Our National System for Medical Device Postmarket Surveillance,” was issued in September 2012. Following the release of the report, the FDA held a series of public meetings and accepted comments on its website to garner stakeholder feedback. The update incorporates the public input it received.
The FDA plans to create a unique device identification number for each medical device product, and it plans to develop interoperability between EHRs and registries that store medical device data. It will also create a mobile app to help providers report adverse events.
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