Clear some space on your regulatory bookshelf! You're going to need room for your copy of the UK's newly-adopted

Punchline: In a final Trump-era rule proposal, FDA makes it easier (far too easy, in our view) to commercialize dozens

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

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

Choosing the right FDA pathway for your product is not easy and can be fraught with regulatory landmines. But by asking

Let's start the day with some much-needed good news from the EC. They've released a new guidance aimed at making it

Acceptance: The Fifth Stage of Regulatory Grief (video) Let's face it - no one likes being told what to do, and

Regulatory Depression? Blame Bad Design Controls (Video) The regulatory submission process can leave most anyone

Quality versus product development. It's a story as old as time - or at least as old as medical device

Bargaining with the FDA - or trying to - is the third stage of regulatory grief, but adopting that as your strategy will