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Transforming FDA


This year could bring sweeping changes to how CDRH regulates the device industry. There is a new Congress, a new FDA commissioner, a new approach to postmarket issues, and at least one piece of major new legislation (the MDUFMA reauthorization). Since so many stakeholders will be taking a fresh look at CDRH, so will we at MD&DI. The changes under consideration may be so sweeping as to affect all of you, our readers, not just those who deal with regulatory affairs.

We want to make sure you don't miss any of this vital coverage. So we will be identifying all articles concerning these major issues with the “” logo, shown here.

When you see an article with this logo, you will know it is calling your attention to an issue that could affect CDRH, the device industry, and you. More such items will appear on our blog at And to help you get the big picture, we are putting all print and online “” articles in one place, at We welcome reader suggestions about topics and angles to explore. Please send them to [email protected].

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