The FDA’s Center for Devices and Radiological Health (CDRH) posted a notice of draft guidance that will require all medical device adverse-event reports to be submitted electronically. While the process of electronic submission of data is a more efficient and traceable means for reporting, it could prove to be a very long and challenging road for the average medical device manufacturer to transition from its current paper-based reporting process to an electronic reporting process.

To ensure success, this transition needs to be very carefully planned out and executed to guarantee continued compliance and ongoing integrity with regard to the company’s product adverse-event reporting and customer satisfaction.

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