De Novo Request

De Novo is the process by which sponsor can file market approval request for new medical
devices or technology where there is no comparable predicate device on the market.
De Novo classification is a risk-based classification process.
Successful De Novo process will lead to a new predicate device that can be referred to bring new
product to market through the 510(k) process. If the De Novo request is declined, then the device
is kept under Class III and the device may not be marketed until it found any substantial
equivalence device.

Steps for De Novo Submission Process

Which device is eligible for De Novo submission?

Device that is new and does not have any predicate.
Risk of device is classified as low to moderate.
FDA issue NSE (Not Substantially equivalent).

De Novo Pathways
 Documents required for De Novo request
The documents required for De Novo submission is almost like traditional and abbreviated 510(k)
but some documents are not required.

Complete all necessary research prior to submission.

Sponsor assures that device should not be substantial equivalent to any existing device.
Sponsor can review this from CDRH, FDA Device classification database, Device classification
under section 510(f).

How much should the sponsor pay?

Please visit MDUFA User Fees to view the current user fee amounts.

RTA Assessment
De Novo submitter must submit an Acceptance checklist with De Novo request. If components listed
in the Acceptance Checklist as RTA items are missing and no justification is given, then the De
Novo request won't be approved and will be given a Refuse to Accept (RTA) classification .

eCopy conversion
Prepare eCopy through e-star program.

How to submit request

Online: Send eCopy through CDRH Portal

By MAIL: Send eCopy of medical device submission to the CDRH Document Control Center (DCC)
at this address:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
 Timeline for De Novo Review

Amandeep Kaur Deol

Jr. Consultant FDA 510(k)