Health IT Pulse:

investigational device exemption


February 19, 2014  11:07 AM

Electronic submission of medical device reports now a requirement

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
FDA, FDASIA, investigational device exemption, UDI

The Food and Drug Administration's finalized rule for medical device surveillance requires manufacturers to submit reports for individual medical device adverse events. The medical device reports (MDRs) are now required to be submitted electronically to the FDA, which can then analyze and store the...

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