The US Food and Drug Administration (FDA) recently announced in a guidance issued on August 23, 2024, entitled ‘Electronic Submission Template for Medical Device De Novo Requests’ that, as of October 1, 2025, medical device manufacturers will have to use only the electronic eSTAR form to submit De Novo applications. The De Novo procedure makes it possible to classify new Medical Devices with low or moderate risk, for which no classification already exists.
Implementation of eSTAR and De Novo Procedure
The eSTAR system, introduced in February 2020 for 510(k) applications, reduces the risk of compilation errors by offering automatic guidance and validation. This system improves the review and digitisation of regulatory applications. The use of eSTAR for 510(k) applications is already mandatory as of October 1, 2023. For De Novo applications, it has so far been optional (voluntarily) and will become mandatory from October 1, 2025.
The De Novo procedure allows the classification of innovative low- to moderate-risk Medical Devices without previous equivalents. If a manufacturer cannot find a ‘predicate’ device for 510(k) submission, it may use the De Novo request. The FDA recommends doing a pre-submission to obtain feedback before applying.
What’s new about the De Novo application guide
The updated guide, published on August 23, 2024, entitled ‘Electronic Submission Template for Medical Device De Novo Requests,’ replaces a draft issued in September 2023 and introduces significant changes. In summary:
- Mandatory use of eSTAR: as of October 1, 2025, eSTAR will be the only accepted format for De Novo requests, replacing previous methods.
- Standards for preparing applications: general standards and details on how to use eSTAR are specified, including content and how to fill them in.
- Technical Screening and Revision Procedures: The FDA will perform a technical screening within 15 days of receiving the application and fees. If the request is incomplete, the sender will be notified by email and will have 180 days to correct the eSTAR form, otherwise the request will be considered withdrawn.
Conclusions
The new guidance represents a significant step towards the complete digitisation of regulatory submissions to the FDA. Moreover, De Novo’s procedures are crucial for bringing innovative devices to market that do not have an already classified equivalent, making this update particularly relevant for companies developing cutting-edge technologies.
As also indicated in the guide, all companies should start using eSTAR as soon as possible to avoid delays in future submissions.
>>> Thema (Italian office) and Thema Corp (US office) experts are available to guide you step-by-step through the process of obtaining the De Novo classification and other pre-market regulatory processes required for Medical Devices to enter the US market.
