De Novo classification requests require a significant investment of time and resources. Many applicants are new to the FDA regulatory processes and need help in putting together a reasonable request. In the last few years, the FDA has tried to help medical device submitters with application formatting via its eSTAR templates. This month they expanded the eSTAR to De Novo submissions.
A new guidance document on De Novo submissions via eSTAR outlines the technical standards for preparing electronic submissions for De Novo classification requests using the FDA’s eSTAR template. The eSTAR template facilitates the collection and assembly of required elements for complete submission, guiding users through questions, text prompts, and integrated databases to ensure all necessary information is provided. It also offers links to relevant regulations and resources to support the submitter.
The eSTAR template ensures that submissions meet technical and content requirements by providing in-built process checks for consistency in the descriptions of devices and the required attachments. For example, if software is involved in the device, a Software Description attachment must be provided. This screening ensures the submission aligns with De Novo classification requirements and that the device type is appropriate for this pathway. If the device is deemed ineligible during screening, the De Novo request may be placed on hold.
In cases where multiple devices are included in one submission, FDA may review them together if they are variations of the same device type. However, if multiple distinct device types are proposed, the submission will be placed on hold until the requester clarifies which device is the subject of the request. The technical screening process occurs within 15 days of receiving the De Novo request, and the review clock begins once the submission passes screening.
The eSTAR template for De Novo requests is currently optional but will be mandatory in about a year, on October 1, 2025.
