The FDA finalized its guidance document Electronic Submission Template for Medical Device 510(k) Submissions in order to introduce submitters to the current resources made publicly available to support 510(k) submissions. A 510(k) is a premarket submission made to FDA to demonstrate that a device to be marketed is as safe and effective as, or substantially equivalent to, a legally marketed device.

The Center for Devices and Radiological Health developed and piloted the use of the electronic Submission Template and Resource (eSTAR) template in 2020 to support the transition to 510(k) submissions solely in electronic format. The Center for Biologics Evaluation and Research initiated a pilot of the eSTAR program in 2022. The program is free to users and consists of a series of prompts within a template intended to guide a user through the construction of a submission. FDA is anticipating that submissions using the eSTAR program will represent a complete submission and are therefore not expected to receive a “refuse to accept” notification.

eSTAR may currently be used voluntarily and will be required for 510(k) submissions beginning October 1, 2023.