Free tool · no account · no AI

De Novo check

De Novo is the route for a new type of device with no valid predicate, when its risks are low to moderate. Answer four questions to see how your device lines up.

Is there a legally marketed predicate with the same intended use?

Yes, a cleared device with the same intended use Similar technology, but a different intended use No predicate I can find FDA found my device not substantially equivalent (NSE)

Does a classification regulation already cover this device type?

The free classification lookup shows FDA's classified device types.

Yes No Not sure

Overall, how risky is the device?

Low Moderate High: life-supporting, implanted long-term, or similar

Could general controls, or general plus special controls, reasonably assure safety and effectiveness?

Special controls are things like performance testing, labeling requirements and software documentation set out for the device type.

Yes No Not sure

See the answer

A screening aid, not a determination. The answer follows FDA's published guidance and cites it, but only FDA decides, through a Pre-Sub, a 513(g) or the submission itself. Confirm with FDA or a qualified regulatory professional. Fees and review goals are planning figures. Nothing you answer is saved.

Read more

De Novo in plain terms covers what a request contains, what a grant creates, and when to talk to FDA first.

Other free tools: Special 510(k) · De Novo · 513(g) · Breakthrough · classification lookup · predicate search · Learn