The De Novo classification is an FDA regulatory mechanism used for new medical devices that are anticipated to be Class I or Class II with low risk when there is no suitable predicate device to claim substantial equivalence.
The FDA announced the final guidance on the electronic submission template for De Novo (FDA-2023-D-3788) on August 23, 2024. This guidance includes on the use of the electronic submission template and resources (eSTAR) within the CDRH Portal for De Novo requests. While the use of eSTAR for 510(k) submissions became mandatory starting October 1, 2023, voluntary submissions are currently required for De Novo. The newly announced final guidance states that the use of eSTAR for De Novo requests will be mandatory starting October, 1, 2025. Therefore, eSTAR is expected to become an essential submission format for De Novo requests in about a year.
Please refer to the link below for details.
Electronic Submission Template for Medical Device De Novo Requests
This final guidance provides submitters of De Novo requests to CDRH and CBER the associated content to support De Novo electronic submissions to FDA.
www.fda.gov
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