FDA Draft Guidance to deregulate MDDS

FDA issued a draft guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. This draft exercises FDA enforcement discretion to essentially deregulate MDDS and Imaging Storage and Coummincation systems despite their classifcation rules. The guidance is at the link provided and proposes the new policy and provides specific wording changes to the Mobile Medical Apps Guidance to accomodate this change. The changes including deregulation of Mobile Medical Apps that serve as a secondary display of data rather then the primary device display such as an App for a doctor that receives data from a nursing station monitor.


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