About FDA eSTAR

On September 29, 2021, the FDA issued a draft guidance: Electronic Submission Template for Medical Device 510k Submissions. The guidance outlines the structure, format, and use of the electronic Submission Template And Resource (eSTAR) for preparing electronic 510(k) submissions

The electronic Submission Template And Resource (eSTAR) is a PDF electronic submission template that guides premarket notification (510(k)) submitters through the process of preparing a comprehensive medical device 510k submission. This template contains:

• Automation (for example, form construction, autofilling);
• Content and structure that is complementary to CDRH internal review templates;
• Integration of multiple resources (for example, guidances, databases);
• Guided construction for each submission section; and
• Automatic verification (i.e., FDA does not intend to conduct a Refuse to Accept review)
• Internal eSTAR form-filling tracking and marked ‘Complete’ when fully compliant
• Blue Help/Notification Screens, Consensus Standards Drop-downs list are context specific

The voluntary eSTAR pilot program aims to improve consistency and efficiency in how the medical device industry prepares 510(k)s and how the FDA reviews these submissions. The FDA will evaluate whether the use of FDA’s free eSTAR produces well-organized submissions that can be reviewed more efficiently, in comparison to submissions prepared as eCopies or with the eSubmitter application, to help promote timely access to safe, effective, and high-quality medical devices.

At the moment, eSTAR can be used on a voluntary basis to construct a 510k submission. The date for mandatory use of eSTAR for 510k will be identified when the draft guidance is finalized. While eSTAR is currently only available for 510k submissions,  the FDA intends to expand the eSTAR program to include other types of pre-market and post-market medical device submissions in the future.