The FDA is ALWAYS Watching

Think that the FDA won't notice your "therapeutic massager" device? Think they have much bigger fish to fry than your

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

This conversation is part of Arazy Group Consultants' Regulatory Rockstar Movement, which I was invited to participate

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

Note: QMSR became mandatory in February 2026, three years after this blog was written. Please see the closing for up to

How do you determine the correct FDA submission for combination products? What IS a combination product? A

Very few days go by without someone asking me to explain the differences between FDA submission types. This most

How do you go about choosing the right predicate device? Say you've developed a new tree-borne fruit and you need to

Blame the snake-oil salesmen. It's mostly their fault that we ended up with so much medical device regulation in the