Electronic Medical Device Report (eMDR) Submissions to CDRH in 2010 Sets New Record

Article title

As we predicted a few months ago, 2010 proved to be a record setting year for CDRH electronic submissions. The pace of submissions picked up significantly in the 2nd half of 2010, with October being the highest submission month (18,096).  Several years ago the device industry was criticized for not embracing electronic submission technology, but now is in a commanding lead over the rest of FDA’s divisions including CDER.

CDRH 2010 Monthly Statistics

Source: FDA

Looking at the numbers from 2006 – 2010 below, it looks like the device industry has embraced this paperless technology and will continue to grow as the mandate looms in 2011.

CDRH 2006 - 2010 ESG Submission Totals

Source: FDA

It will be interesting to see if the rate of growth will continue at this rapid pace, or will level off. We’ll keep you posted.

More information about electronic medical device reporting solutions.

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