Currently, all medical device submissions for 510(k), De Novo, and Pre-Submissions may voluntarily use eSTAR. The intention of the program is to enhance the quality of submissions by providing a standardized format so submitters can ensure submissions are complete. Additionally, the review process can be streamlined and more efficient.
Starting October 1, 2023, all 510(k) submissions unless exempted must be submitted as electronic submissions using eSTAR.
The eSTAR is a template that guides the user through creating a 510(k) submission. The template is automated and includes integrated databases such as FDA product codes and FDA recognized voluntary consensus standards. Applicable links to regulations and guidance for the submitter to reference are also provided in the eSTAR. The structure of the eSTAR closely follows the “SMART” 510(k) review memo template. Because the template should ensure a complete submission, the eSTAR submissions are not anticipated to undergo a refuse to accept process. The FDA does intend to utilize a virus and technical screening process. The technical screening process will verify the responses and ensure there is at least one relevant attachment per each attachment question.i
The new process for submissions should streamline and simplify the preparation of a submission and will lead to more efficient review of submissions, allowing for timely approval of safe and effective medical devices.
[1] Electronic Submission Template for Medical Device 510(k) Submissions – Guidance for Industry and Food and Drug Administration Staff. September 22, 2022.
