De Novo Request Submission Process
When is a De Novo Request Applicable?
A medical device may be eligible for a De Novo Request if a manufacturer determines that the device under development does not have a predicate device and that it meets the expected standards for classifying a device into Class I or Class II. This means that the manufacturer determines the device to be of low or moderate risk and believes that safety and effectiveness of the device can be determined through implementing general controls or general and special controls. FDA will primarily evaluate the risks associated with the device to assign a classification. If the FDA finds evidence for a low-to-moderate risk device to be inadequate, the device will be classified as Class III and additional testing may be required. The medical device may have to go through the more stringent PMA submission pathway to get approval. If the FDA determines the device under review to have a predicate device, the De Novo Request will be declined, and the MFG will instead submit a 510(k).
A medical device may also be eligible for De Novo Request if the medical device was originally seeking approval under a 510(k) submission, but the FDA determined the device to be non-substantially equivalent (NSE) due to lack of an identifiable appropriate predicate device.
Though not required, the FDA encourages manufacturers to submit a pre-submission for a De Novo Request as the agency can provide feedback on whether the device may be eligible for the De Novo classification process. A pre-submission can provide advantage by getting FDA’s preliminary perspective on potential regulatory controls needed for the medical device and by getting feedback on test methods required to collect clinical/nonclinical data to support De Novo submission. More details on the pre-submission can be found in the De Novo Classification Process guidance document.
De Novo Request Content
A De Novo Request must include all the applicable content elements per the Acceptance Checklist for De Novo Classification Requests in the Acceptance Review for De Novo Classification Requests guidance document. The De Novo Request review can be delayed or refused if the application is incomplete. Examples of critical information that go into a De Novo Request submission include a coversheet, device description, clinical data (if applicable), non-clinical data, and Benefit-Risk determination. More details on the De Novo Request content can be found in the Acceptance Review for De Novo Classification Requests and De Novo Classification Process guidance documents.
De Novo Request Submission
A De Novo Request can be submitted as an eCopy or eSTAR.
The FDA defines eCopy as an electronic version of the medical device submission created and submitted on a compact disc (CD), digital video disk (DVD), or a flash drive. The submission is accompanied by a paper copy of a signed cover letter. Detailed information on eCOPY can be found in the eCOPY Program for Medical Device Submissions guidance document.
eSTAR allows manufacturers to submit a De Novo Request submission via an interactive PDF form. With a standardized format, submitters ensure their submission is complete and the FDA can review the submission more efficiently to help promote timely access to safe, effective, and high-quality medical devices. Detailed information on eSTAR can be found under Voluntary eSTAR Program on the FDA website.
A user fee will be required to be paid before submitting the De Novo Request. Detailed information on the user fee can be found under MDUFA User Fees on the FDA website.