Executing FDA Approval, page-3

The Emergo website provides a good summary of the FDA de novo submission and assessment process for medical devices. Provided the classification requested is suitably justified in the submission and no additional information required, granting of either Class I or II can be expected within 120 days.

Assuming the application is submitted by the end of March, a successful grant therefore would allow ResAppDx to be marketed in the US from August onwards.


“FDA De Nova Submissions for new devices
Entirely new devices are automatically considered to be Class III in the US. However, many new products are not high risk. This is why the FDA has the "de novo" process. You may consider filing a “de novo” submission if the FDA determines, through means such as a 513(g) or Pre-Submission, that your device is a “novel” with no existing classification or predicate device on the market. Within 120 days after your de novo submission, the FDA will determine if your device is Class I or II and may issue an entirely new product code and regulation number. If rejected, your device will remain Class III. Read this De Novo guidance document from the FDA.”

“What happens once a de novo is granted?
After a de novo is granted by the FDA, the specific device and device type is classified as Class I or Class II. The device may then be marketed immediately and serve as a predicate device.”

The flowchart below summarises the requirements and review process.