United States · Medical Devices

De Novo Classification in the United States

A practical guide to De Novo Classification for medical devices sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Manufacturers and importers of medical devices and IVDs; Brands distributing devices through local partners

Authority

U.S. Food and Drug Administration

Legal basis

FD&C Act section 513(f)(2)

Local representative

A local licence holder or authorised representative is required

Timeline

Registration can take months; plan early

Cost

Clinical evidence and QMS audits dominate cost

If you do not comply

Import ban, seizure, and enforcement action

Who needs this

Manufacturers and importers of medical devices and IVDs
Brands distributing devices through local partners

Documents you need

Regulatory classification and registration
Clinical or performance evidence
Quality management system certificate
Labelling and instructions for use

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Regulatory classification and registration
Clinical or performance evidence
Quality management system certificate
Labelling and instructions for use

How to comply

Classify the device under local rules
Prepare technical documentation
Complete registration or notification
Maintain post-market surveillance

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: De Novo Classification — United States
Product category: Medical Devices
Authority: U.S. Food and Drug Administration
Legal basis: FD&C Act section 513(f)(2)

Documents we already have:
  1. Regulatory classification and registration
  2. Clinical or performance evidence
  3. Quality management system certificate
  4. Labelling and instructions for use

Questions:
  1. Does our product fall under De Novo Classification in the United States?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Registration can take months; plan early.

Clinical evidence and QMS audits dominate cost.

Common rejection reasons

Wrong risk classification
Clinical evidence insufficient
QMS certificate not accepted
Labelling incomplete

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.

Official sources

FAQ

Who needs De Novo Classification in the United States?

Manufacturers and importers of medical devices and IVDs. Brands distributing devices through local partners. The importer of record normally holds the evidence.

What documents do I need for De Novo Classification?

Regulatory classification and registration; Clinical or performance evidence; Quality management system certificate; and labelling and instructions for use.

What is the first step for De Novo Classification?

Classify the device under local rules, then prepare technical documentation. Registration can take months; plan early.

How long does De Novo Classification take?

Registration can take months; plan early.

How much does De Novo Classification cost?

Clinical evidence and QMS audits dominate cost.

What happens if I sell without it?

Import ban, seizure, and enforcement action.

Who regulates De Novo Classification in the United States?

U.S. Food and Drug Administration.