Resources

The rules everyone in this category is working inside.

Short, checkable explanations of how device clearance actually works, written for the people who have to talk about it all day.

• What a 510(k) clearance actually says

  Clearance and approval are different things, and the difference is the reason your reps get stuck at the booth.

• Device classes, and where aesthetic devices sit

  Three classes, set by risk. Most of this category lands in the middle one.

• On-label, off-label, and who is allowed to say what

  A physician and a manufacturer are governed by different rules, which is why they can say different things about the same device.

• Before-and-after photographs: what consent has to cover

  A clinical image used in marketing needs written authorisation, and the authorisation has to say specific things.

General information for medical professionals, not legal or medical advice. Regulatory status varies by product and changes over time. Verify a specific device against its own clearance record before relying on anything here.