"FDA Cleared" Doesn't Mean What Most Headlines Imply

A surgeon reading a clearance headline wants to know one thing: has this been proven safe, or just allowed onto the market.

The answer depends entirely on which of three regulatory pathways the device went through, and most headlines never say which one.

The Three Doors

A 510(k) requires a device to be substantially equivalent to a predicate device already on the market, and it doesn't require independent proof of safety or effectiveness, only that the new device is similar enough to something already cleared.

This is the pathway for the overwhelming majority of devices, with over 3,000 clearances in 2022 alone, and the FDA typically reviews them in 30 to 90 days.

A De Novo request is for genuinely novel devices that have no predicate but present low to moderate risk, and it creates a brand new device category that the device itself becomes the first predicate for.

A PMA, or Premarket Approval, is reserved for the highest-risk devices, and it requires independent clinical evidence demonstrating safety and effectiveness, making it the most demanding of the three pathways.

"Cleared" and "Approved" Are Not the Same Word

The FDA reserves the word approved specifically for devices that went through PMA, where the agency made an independent finding of safety and effectiveness.

A 510(k) or De Novo device is cleared, not approved, a distinction that reflects a real difference in what was actually proven.

Why This Matters for Reading the News

Fewer than 10 percent of 510(k) devices are cleared with any supporting clinical evidence at all; most rely entirely on the assumed safety of the predicate they're compared to.

So a headline announcing FDA clearance for a device with new features is very often a claim about similarity to something older, not new independent proof about the new feature itself.

The pathway is the second sentence every clearance story needs, right after what the device actually does.

Source: U.S. Food and Drug Administration

The AI Claims Audit applies this same pathway-by-pathway scrutiny to every company currently marketing "AI-powered" surgical claims.