{"id":33113,"date":"2024-09-19T16:24:59","date_gmt":"2024-09-19T14:24:59","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/"},"modified":"2024-09-19T16:26:28","modified_gmt":"2024-09-19T14:26:28","slug":"fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/09\/19\/fda-annunciata-la-data-di-implementazione-di-estar-per-le-richieste-de-novo-nella-guida-aggiornata\/","title":{"rendered":"FDA: eSTAR Implementation Date Announced for de Novo Applications in Updated Guidance"},"content":{"rendered":"

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’ <\/strong>that, as of<\/strong> October 1, 2025<\/strong>, medical device manufacturers will have to use only the electronic eSTAR<\/strong> 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.<\/h2>\n

Implementation of eSTAR and De Novo Procedure<\/strong><\/h2>\n

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.<\/p>\n

The De Novo procedure allows the classification of innovative low- to moderate-risk<\/strong> 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.<\/p>\n

What\u2019s new about the De Novo application guide <\/strong><\/h2>\n

The updated guide, published on August 23, 2024, entitled ‘Electronic Submission Template for Medical Device De Novo Requests<\/strong>,’ replaces a draft issued in September 2023 and introduces significant changes. In summary:<\/p>\n