FDA: eMDR Guidance Probably Won’t Happen This Summer

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“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.

Showing 4 comments
  • Reply

    Regardless if it happens this summer or not, medical device companies would be better off using electronic submissions to FDA, while at the same time tying it in automatically to their complaint handling system.

  • Reply

    I agree with Tamar June:, you would be better off to start using eMDRs for submissions to FDA now before FDA’s dead line suddenly becomes due and everyone is scrambling in panic to comply with the new requirement, not knowing what to do, making mistakes. Electronic submissions make sense and saves cents and time.

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