FDA Moves to Mandate eMDR by February 2011; Will Device Firms be Ready?

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

UPDATE 2: (July 2010): FDA: eMDR Guidance Probably Won’t Happen This Summer.

UPDATE 1: (June 2010): Please see our updated blog on the new timeline here.

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A telling stat that came out of today’s press teleconference announcing the draft guidance: While about 80% of the nearly 500,000 submissions CDER gets already come in electronically, on the CDRH device side it’s only about 15%.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Industry has 90 days to comment on the draft guidance.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Download the PDF version of the draft guidance here.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.