Numbers don’t lie. Reviewing the year-end numbers for FDA’s CDRH electronic submissions (AS2 Electronic Submissions Gateway) provides some eye popping stats.  This is an early indicator that electronic medical device reporting submissions have significantly increased over 2008, and certainly suggests they’ll rise even faster this year after the final rule is published.

Comment period on the draft guidance ended November 2009. The final ruling is expected within weeks. According to some FDA insiders, many were relieved the agency wasn’t overwhelmed with comments (slightly over two dozen comments were filed), and the ones received were definitely “workable”.

So, what did 2009 numbers look like?

As the chart shows, early 2009 got off to a slow start, but picked up significantly in the fourth quarter of the year.

But when comparing 2008 vs. 2009, total submission numbers jumped from 4,619 to 21,296. It’s apparent that the device industry has picked up the pace when it comes to electronic submissions to FDA. And if this isn’t a wake up call for device companies to move away from paper 3500A submissions to eMDR, we don’t know what is.

We’ll be keeping a close eye on this through 2010.

Well, they finally did it.

After more delays and internal intrigue than your typical Hollywood Blockbuster, the FDA today unveiled their proposed guidance for ultimately mandating electronic submission of mandatory adverse event reports.

It’s going to save time (paper submissions take up to two weeks to process at FDA HQ) and money for both industry and the agency.

But will device firms be ready?

A telling stat that came out of today’s press teleconference announcing the draft guidance: While about 80% of the nearly 500,000 submissions CDER gets already come in electronically, on the CDRH device side it’s only about 15%.

“We have some work to do” on the device side, David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA’s Center for Devices and Radiological Health (CDRH), observed mildly at today’s press conference.

Why are pharma firms so far ahead of device firms here? It’s odd because in many ways device firms are viewed as more tech savvy and more of the early adopter type. But the fact that pharma companies are generally much bigger, with much deeper pockets, probably explains some of why they have such a big electronic jump on their device brethren.

Device companies have also complained that the FDA hadn’t made its eMDR expectations clear. But that excuse won’t really hold now that the agency has issued a pretty straightforward guidance.

Industry has 90 days to comment on the draft guidance. After that, the agency will take a few months maximum to digest and perhaps take advice from those comments. Then they’ll issue a final rule that will mandate esubmissions for mandatory reporting (such as adverse events) a year from then.

So, mark your calendar for sometime around February 2011 for a mandate from the agency.

Will device firms be ready? There’s no excuse not to get with the program now.

Download the PDF version of the draft guidance here.

More information about AssurX’s eMDR solution here.

Back in October 2008, we posted this on our eMDR Updates page on our website:

No definitive release date for eMDR draft guidance documents from the FDA

In a recent Webcast, Indira Konduri of the FDA indicated that they were still working on the proposed rule making for electronic medical device reporting (eMDR). No specific time line has been released. However, she did hint that the time frame to implement (if mandated) would most likely be one year. As with any other proposed guidance, there will be an open public comment period.

Another FDA insider told us that the guidance documents would either be released at the end of this year, or early 2009. Original scheduled release date was 2Q of 2008. We’ll keep you posted as soon as we find out.

According to FDA officials we spoke to a couple of weeks ago, there is still no time-line for releasing the guidance documents to the industry. Apparently, everyone is waiting on the new administration’s leadership team for the FDA to be put in place before proceeding any further. However, considering the significant IT investments that the FDA committed to in 2008, mandating electronic medical device reporting is not a matter of if, but when. We’ll keep you posted.