The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) review process. It’s called, eSTAR, or electronic Submission Template And Resource.
Today’s guest is Mike Drues of Vascular Sciences. Together, Mike and Jon Speer discuss the details of the eSTAR Pilot Program to help listeners understand what they need to know and do as medical device professionals.
“The information that goes into this template itself, that information is exactly the same.”
“It’s another way that we can try to increase the efficiency of the 510(k) review process.”
“We already have a ton of tools out there, a ton of guidance out there on how to prepare 510(k)s...and yet, still so many people screw it up.”
“eSTAR is nothing more than TurboTax for 510(k)s.”
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