Device Makers Smash Record in 2010 with eMDR Submissions to FDA

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In July of this year, we blogged about how the mid-year electronic medical device reporting submissions had soared to record levels. Now it looks like it’s actually going to be a record breaking year. The FDA has seen record breaking submissions by CDRH, for the first time being outpaced by CDER by almost twofold. In the past few years, CDER submissions to FDA far exceeded those by CDRH.

As you’ll see in the chart below, submissions to CDRH  have grown significantly in 2010.

But what’s even more eye-popping is the comparison of electronic submissions to CDRH for 2009 vs. 2010 (through October) shown in the chart below.

So what’s driving this surge? Many contributing factors can play into these numbers. Many companies have embraced FDA’s options for electronic submissions, and many have implemented commercial off-the-shelf electronic medical device reporting (eMDR) software as part of their overall complaint handling and quality management system. Other factors could include increased vigilance over reportable submissions, numerous new devices that have come to market, anticipation of electronic submissions mandate by FDA, as well as increased device scrutiny from FDA, health professionals and the public at large. Even though we didn’t see the expected mandate on eMDR in 2010, it is listed on CDRH’s priorities for 2011.

Some industry analysts say that device makers, generally smaller entities than pharmaceutical companies, had been slower to embrace eMDR because they didn’t have the same money or staff. But those days are clearly over.

We’ll revisit the 2010 numbers again in January 2011.

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