来源：Regulatory and Compliance
The last year of the Obama Administration will likely be remembered by FDA-watchers for two major agency initiatives affecting medical device regulation: cybersecurity requirements and CDRH’s establishment of a National Evaluation System for “real world” device monitoring, one of three strategic priorities for the 2016-2017 timeframe.
Each of these has been under congressional scrutiny, something that both the Trump Administration andthe reinvigorated Republican majorities on Capitol Hill seem likely to continue.
Cybersecurity vulnerabilities first came under notice in a 2005 FDA guidance, but did not get serious attention until two years ago when the Center issued a
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