How FDA Changes in 2025 Are Shaping Medical Device Regulation

If you’ve been watching the FDA lately, you might feel like you’re watching a daytime soap opera rather than a

This quick-read pulls from my “Medical Device 101” presentation, a session packed with field-tested guidance for

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

QMSR and ISO 13485 - talk about a tale of two regulations. QMSR and QSR do sound practically the same, but that one

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

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