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De Novo in plain terms

De Novo is the route for a new type of device: nothing legally marketed is a valid predicate, yet the risks are low to moderate, so general controls, or general plus special controls, can provide a reasonable assurance of safety and effectiveness. Without it, such a device would land in Class III by default.

Two ways in

• Directly, when you conclude no predicate exists.
• After a not-substantially-equivalent (NSE) decision on a 510(k).

What a request contains

A description of the device and its intended use, why no predicate fits, a benefit-risk assessment, the risks to health and the proposed special controls that mitigate each, and the performance data (bench, software, biocompatibility and, where needed, clinical) that support them. A Pre-Sub to agree the special controls and testing first is common, and usually worth it.

What a grant creates

A new classification regulation, with its special controls. Your device can then be a predicate, so later devices of the same type go the 510(k) route.

Time and cost

FDA's MDUFA goal is a decision within 150 review days. The FY2027 user fee is $191,020, or $47,755 with small-business status. Try the De Novo check.

Sources

• De Novo Classification Process (Evaluation of Automatic Class III Designation) (FDA guidance)
• 21 CFR Part 860, Subpart D: De Novo classification
• Medical Device User Fees (FDA)

General information, not regulatory advice. FDA decides every classification and submission; confirm your route with FDA (a Pre-Sub or a 513(g)) or a qualified regulatory professional. Fees and review goals are planning figures; check FDA's current schedule.

More: Choosing an FDA pathway · Traditional, Special or Abbreviated 510(k) · 513(g) requests in plain terms · Pre-Subs (Q-Submissions) in plain terms · The Breakthrough Devices Program