De Novo Classification Request

What is the De Novo pathway?

A novel device without a legally marketed predicate is classified into Class III by operation of law unless the FDA reclassifies it. The De Novo process provides a route to Class I when general controls are sufficient, or Class II when general and special controls provide reasonable assurance of safety and effectiveness. A granted request both authorizes the device and creates a new device type.

When is De Novo the right pathway?

A sponsor may submit after a 510(k) receives a not-substantially-equivalent decision, or submit directly when it determines that no legally marketed predicate exists. The strategic question is not simply whether another device looks similar: intended use, technological characteristics and the risks requiring controls all matter. A weak predicate argument can add an unsuccessful 510(k) cycle before the De Novo review even begins.

What happens after a De Novo is granted?

The FDA establishes a classification regulation and product code. For a Class II device, the classification includes the special controls that apply to the new device type; a Class I De Novo is governed by general controls rather than device-specific special controls. The granted device may then serve as a predicate for later 510(k)s of the same type, so the classification order becomes an important public reference for both the first sponsor and later entrants.

How does De Novo review compare with 510(k) review?

A De Novo request must characterize the device's benefits and risks and explain how the proposed controls address those risks. The current MDUFA decision goal is 150 FDA days, compared with 90 FDA days for a 510(k), excluding applicable time on hold. Evidence needs are device-specific: clinical data may be necessary, but are not universal. Digital health, diagnostics and AI-enabled devices are among the technologies that have used De Novo authorization in the United States.