Updated cybersecurity requirements for medical device premarket submissions, Abbreviated and Special 510(k) program refinements, and medical software policy changes stemming from the 21st Century Cures Act rank highly among topics for a new list of guidance documents the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to publish during the agency’s 2019 fiscal year.
Get the full story here at the Emergo Group’s blog.
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