FDA Submission Pathways

Congratulations - after years of pouring your heart, soul and ingenuity into the project, you've developed a brilliant

Today we're talking about the third step in the five steps to market process - determining the right class and pathway

Can you name the five steps to market required to move your product from concept to launch? Obviously, we're talking

As you must know by now, the FDA made eSTAR 5.0 mandatory for 510(k) submissions in October 2023. It's also available

Imagine, if you will, an established medical device player and their newly-acquired subsidiary trying to flex their

Can you explain the difference between intended use and indications for use? 🤔 The terms are NOT interchangeable, but

Can YOU explain the differences between FDA authorization, clearance and approval? 🤔 I hear people use the three

You and FDA are going to get pretty cozy before you are granted clearance – the 'marriage certificate' in our little