FDA Proposes Mandatory MDR eSubmissions: What's Next? –The long awaited electronic medical device reporting (eMDR) train is finally leaving the station; and
it’s due to arrive in mandatory form around February 2011. The Food and Drug Administration (FDA) has just proposed amending post-market safety reporting regulations for three of its centers to
require that manufacturers and other facilities subject to current reporting requirements submit
their reports in electronic format.
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eMDR submissions are already on the rise this year compared to 2008
What changes, and what doesn't with eMDR
Why the FDA is mandating this change, and what it means for you
Former FDA inspector encourages firms to embrace this technology now.
The industry's opportunity to weigh in on the issue
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