Mid-year Electronic Medical Device Report (eMDR) Submissions to CDRH Soar to Record Levels

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In January of this year, we took a look at the overall numbers for electronic medical device reporting (eMDR) submissions to the CDRH/FDA. As we predicted, those numbers have risen significantly in the first half of 2010, even though the final rule still has not been published, and probably won’t happen before the end of the summer. Comparing the first six months of 2009 vs. 2010 [see chart below], electronic submissions are up dramatically.

eMDR Submissions 2010 vs. 2009 – First Six Months – Source: FDA

The all-time monthly record was set in June 2010 with 7,755 electronic submissions, and for the first six months of this year they’re up 74% over total submissions in 2009 (21,296 total in 2009 vs. 36,962 first six months of 2010). Even without the eMDR final rule published, companies are taking advantage of paperless electronic submissions to FDA. As Indira Konduri, CDRH eSubmissions Program Manager once told us, it’s better to get on board with the FDA now, rather than wait. I’d take that advice and get it done now, before the final rule is published and everyone rushes to get on board.

It will be interesting to see what happens for the rest of the year.

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