Mixed Reviews by Medical Device Companies on FDA’s ‘Free’ eMDR Option
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 firstname.lastname@example.org.
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 email@example.com