In a few short months, a final rule from the FDA will require devicemakers to begin filing medical device reports electronically.
Once you begin filing electronically, the FDA will expect you to file everything electronically, including: initial reports; supplemental/follow-up reports; file attachments (as PDFs or zips); and source (e.g., user facility) reports.
It’s a learning curve, best climbed early, advises the FDA’s Indira Konduri: “Assistance from the FDA will be easier now — before it’s mandatory — and you’ll be ready to go when eMDR is mandated.”
Here’s your opportunity to have an FDA official answer your questions — and more. Read on ...
For devicemakers, a major change looms in dealings with the FDA. Sometime this summer, the way reports of death and serious injury are filed is to go electronic.
No more paper. No more Excel spreadsheets. You have a lot to learn about eMDR ... and only a short time left to do it.
Who better to ask for guidance than the FDA?
Mark your calendar for Thursday, July 21, when an FDA expert will be on hand to answer your eMDR questions — all of them.
FDAnews has invited CDER official Eugene Reilly for 90 minutes of discussion and Q&A. And you can join in without ever leaving your desk.
The issue is 21 CFR 803, the rule requiring devicemakers to report serious and fatal events to the FDA. More than 600,000 reports are filed each year.
Two years ago, the FDA proposed switching to electronic filing. Despite criticism of the proposed regulation, the final one is expected to show only minor changes, including the following:
Plan on taking extensive notes as Mr. Reilly covers:
eMDR Conversion and Implementation is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your office at home.
And, of course, Mr. Reilly will take your questions. Simply submit them via email, and you’ll have answers for you by the time the session ends.
Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break your budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.
With implementation mere months off, make sure yourcompany is prepared. Sign up now.
Spread the word throughout your organization. Make particularly sure to notify the following key staff:
Eugene Reilly is a public health analyst in FDA's Center for Devices and Radiological Health Office of Surveillance and Biometrics, specializing in systems that process, display and analyze medical device adverse event information. He also maintains the CDRH Event and Evaluation Codes used in MDRs. He has a background in programming, with expertise in XML, Python, and Java for databases, web-based applications, and computer graphics.
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