FDA has begun requiring electronic De Novo submissions for new medical devices

Editor's Note

Beginning October 1, the Food and Drug Administration (FDA) is mandating that all De Novo classification requests be submitted electronically using its eSTAR system, according to a final rule and guidance issued by the agency. As detailed in the September 30 release, the shift marks a procedural change aimed at standardizing and streamlining submissions for novel medical devices that lack legally marketed predicates.

The De Novo pathway allows manufacturers to classify innovative devices into Class I or II when general or special controls can reasonably assure safety and effectiveness. Once granted, a device may serve as a predicate for future 510(k) submissions. The final rule establishes criteria for requests, including format, content, acceptance review, and the FDA decision-making process.

Manufacturers have two options for filing: after receiving a “not substantially equivalent” determination on a 510(k), or proactively if no predicate exists. The FDA encourages sponsors to seek feedback through its Q-Submission program before filing. Required content includes administrative details, device description, risk-benefit analysis, clinical and nonclinical data, and supporting information such as sterilization, biocompatibility, and software testing.

The new eSTAR system automates much of the acceptance review, including virus scanning and technical checks. Submissions deemed incomplete will be placed on hold, and if deficiencies are not corrected within 180 days, the request will be considered withdrawn. Once accepted, FDA aims to issue a decision within 150 review days, excluding hold periods.

Decisions can result in a grant, decline, or withdrawal. A granted De Novo request establishes a new device classification and permits marketing, while a declined request leaves the device in Class III, requiring premarket approval for authorization. The agency also outlines strict timelines for addressing deficiencies. If a request for additional information is issued, sponsors have 180 days to respond or risk automatic withdrawal.