FDA eSTAR Program
The FDA implemented the electronic Submission Template And Resource (eSTAR) interactive PDF form and submission process for all non-exempt device 510(k) submissions on October 1st, 2023. The guidance for this new process expresses that the intent of the eSTAR Program is to ensure submissions contain all of the information needed by the FDA to perform a substantive review.
An update from the FDA on August 22, 2024 announced that a final guidance was issued regarding De Novo requests also being submitted via eSTAR. This is currently voluntary, but will also be required starting October 1st, 2025. FDA also states that 513(g) requests and PMA and Q-Submissions can also now be made via eSTAR as well.
This process has helped to ensure FDA submissions contain all of the required elements and decrease the time spent going back and forth between the FDA and medical device manufacturers. Though eSTAR has helped clarify and streamline the submission requirements, understanding the necessary elements and obtaining all of the required documents can be overwhelming.
The DPDC team has walked many medical device manufacturers through this process, ensuring quality submissions and cutting down on delays getting devices to market. For help understanding the eSTAR process, and ensuring your team is able to make a quality submission up front, reach out to us at DPinfo@dpdcoline.com or 804-965-3981 for a free initial consultation. We look forward to helping you navigate FDA submissions and all medical device regulatory compliance needs!
