FDA to Industry: eMDR is Coming so You'd Better Get Used to it

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

While I wasn’t too happy that the FDA scheduled their series of eMDR (Electronic Medical Device Reporting) Webinars on Friday afternoons, I have to admit that last week’s first session was worth the time.

Aside from a very helpful overview of how the eMDR system works, and generally effective answers to dozens of user questions, the agency also took the opportunity to stress that for eMDR, it’s a matter of when not if.

“It is going to happen,” FDA Public Health Analyst Eugene Reilly said during the session. “I hope it is this summer,” he added.  So while the timing remains an open question, it’s clear that eMDR will be mandated.

It could be this summer. It could be a few months after that. But it’s coming.

Reilly also confirmed that the final guidance will grant industry a one year grace period from the date of the rule promulgation. Translation: You’ll have a year from the date of the rule mandating eMDR before you have to be ready to do it.

Reilly thought many firms could be ready in a matter of weeks, though he allowed others may need more time.

Upcoming eMDR sessions are slated for June, August, September and November.

For more info on the benefits of eMDR and how it works, go here.


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