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.

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.

“Check back in August,” FDA spokesman Dick Thomspon told us this week when we asked if the eMDR guidance was coming out anytime soon. “The guidance is not yet complete,” Thompson said. “At this point, I would not expect this to be issued before the end of the summer.”

The FDA has missed several unofficial deadlines for the guidance, others in and close to the agency have told us in recent months. The latest missed deadline was June, when several folks inside the agency told us and others off the record that it was going to be issued that month.

Well, that didn’t happen.

It’s unclear exactly what the cause of the delay is; we’ve heard from those inside the agency who say it’s more about workload and shifting priorities than any guidance content issue, e.g. the eMDR guidance gets shoved off someone’s desk when something else “more important” comes up. More ominously, we’ve also heard some rumblings that the eMDR process is getting a little political much like the Part 11 process did.

At any rate, the agency asked us to check back in August.

Have a nice summer.

Remember that old expression “you get what you pay for”? Well, it’s a cliché, but most of the time these oft-used phrases are oft-used because they have an underpinning of truth. This brings us to the FDA’s free eMDR options for low and high-volume submissions.

In the past few days we’ve connected with a number of folks who either tried it and liked it, tried it and hated it, and/or were afraid to try it because of all the horror stories they heard.

None wanted to speak on the record, but if you are considering going the free route, their comments are, to use another cliché, food for thought.

“We talked to people from several companies and they found creating the files was still considerably more challenging than it should have been,” a medical device QA official told us. Her bottom-line: “We evaluated eMDR in 2009 and were strongly encouraged by others NOT to utilize” it.

On the other side of the ledger (there’s another cliché, for those keeping score), we heard from at least some medical device companies that said the experience was fine. Example: One told us they’d recently filed their first eMDR, and the report was posted on the FDA’s MAUDE database just under a month later.

And it appears the FDA is at least working to improve its eMDR offerings. Earlier this week, for example, the agency issued a bulletin aimed at high volume submitters in its eMDR user group . The agency told those using a gateway to gateway connection using AS2 or thinking of using a high volume solution in the future that the Implementation Specification found in the Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) files has been updated with some important information.

They boiled down to this:

1) Under the section titled “How do I know my submission reached CDRH?” where the 3 acknowledgments sent via the ESG are discussed, they added the following: “For those reporters using a B2B account (i.e. a gateway to gateway connection) using AS2, you should not rely on the “Content-Type” header for determining how the acknowledgments are processed.  Acknowledgments should be processed based on the file extension and actual content, and your systems should be programmed accordingly.”

This was added to address the issue where the content type sent by the Electronic Submissions Gateway (ESG) in test and production differ, the agency explained.

2) Under the section titled “Can I submit attachments?”  the FDA added an instruction:  “Please limit each attachment to 50 MB in size.”

Worth noting: The FDA said anything larger might cause its loading programs to stall.

3) The FDA also added a new question/answer in the FAQ section:
Q:“Electronically submitted adverse event reports do not have all the fields found in the 3500A form able to be mapped. How should we send information that is not able to be mapped to a 3500A field?”

A: “Correct. Some fields such as G5’s check boxes for combination product, pre-1938, and OTC product are not available for mapping. If you would like to indicate this information or any information that is not mapped, please use section H10 (manufacture narrative) to indicate this information.”

Apparently many reporters already have noticed this, but the agency felt it was helpful to have it noted in the implementation file.

The FDA also tried to deal with some other eMDR issues, too, for WebTrader users.

“The FDA Electronic Submissions Gateway (ESG) has heard from trading partners, industry submitters, and ESG account holders about difficulties logging in to the WebTrader portal. The ESG team has been troubleshooting the issue and has found that the large size of some WebTrader inboxes has been causing login difficulties,” the FDA said.

Because many users have left large numbers of old messages in the WebTrader inbox, the FDA ESG staff announced it would delete all messages other than the most recent 20 messages on Monday, June 14th, 2010 at 1PM EDT.

If you haven’t read your messages or if you might want to save them because they have important information from the FDA, you need to open your WebTrader inbox this week and save them to your own computer or a network location your company defines, the agency said. Otherwise, if you don’t read and save your messages before the deadline, all messages beyond the last 20 will be deleted.

The FDA’s other helpful hint: In order to ensure good WebTrader performance in the future, please save a copy of the receipt and acknowledgment files immediately upon receipt and delete copies from your WebTrader inbox or ensure that the WebTrader inbox has a reasonable number of past messages (i.e. <20).

Direct questions/concerns to the FDA ESG staff at esgreg@gnsi.com.

And if you’ve got any great or horrific eMDR experiences to share with us (off the record, if you prefer) please contact me at mcausey@edataintegrityreport.com

UPDATE! (July 2010): FDA: eMDR Guidance Probably Won’t Happen This Summer.

Lucy of “Peanuts” fame liked to ask Charlie Brown to come kick that football, only to yank it away at the last minute. That’s kind of how I feel waiting for the FDA to release its final eMDR rule.

Officially, the FDA isn’t saying much publicly. But well-placed sources within the agency have told us in the past that it was “coming soon,” even going so far as to say many months ago that it would be released February 2010.

Guess what? The agency missed that deadline, too. We’re hearing it’s been delayed for a slew of reasons; and few, if any, have to do with the content in the rule itself. Indeed, the agency has been surprised how little comment the eMDR rule proposal received. It’s no longer very controversial, and industry realizes that it is going to happen.

And I feel like Charlie Brown again, but here goes: FDA inside sources told us yesterday that it will be released next month. If that new deadline holds, it is also likely to be mandated within a year of its release, so mark June or July 2011 on your calendar for that.

Indeed, CDRH even placed eMDR at #4 on its top priorities list for 2010.

But the FDA has had its hands full and not enough hands to juggle it all. So, chalk the eMDR delay up to internal FDA issues, e.g. lack of staff, other “higher priorities” knocking the eMDR rule off a person’s desk while they put out another fire, etc.

The agency is committed to eMDR, and industry should be too. Once it is up and humming, it will improve productivity, reduce errors, and cut some compliance costs, too.

Watch this space for the latest developments.

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.