Health IT Pulse:

UDI


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...

September 25, 2013  12:19 PM

FDA finalizes long-awaited guidance on regulation of mobile medical apps

Don Fluckinger Profile: Don Fluckinger
app regulation, FDA, mHealth applications, UDI

Making official a preliminary document published July 21, the Food and Drug Administration (FDA) laid out its plan for regulating mobile medical applications, or...


September 24, 2013  12:59 PM

Final FDA rule sets up UDI system for medical devices

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
medical device security, medical devices, mHealth applications, UDI

The U.S. Food and Drug Administration (FDA) released its long-awaited final rule for unique device identification (UDI) system for medical...


September 11, 2012  12:25 PM

FDA calls for increased cooperation in UDI regulation

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio
EHR, FDA, Health IT, UDI

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health released its preliminary report calling for more widespread use of


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