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# eSTAR Template ‘Early Learnings’: Regulation Expert
- URL: https://www.fdaweb.com/estar-template-early-learnings-regulation-expert/
- Published: 2023-03-01T12:00:00.000Z
- Updated: 2026-09-14T18:17:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153881

With the 10/1 deadline for the required use of FDA’s electronic Submission Template and Resource (eSTAR) templates for 510(k) submissions approaching, Hyman, Phelps & McNamara principal medical device regulation expert **Adrienne Lenz** says there is a bit of a learning curve in determining a good process for developing 510(k)s in the new format, especially when collaborating with subject matter experts and reviewers and using cloud-based file sharing. Writing in her firm’s *FDA Law Blog*, Lenz [says](https://www.thefdalawblog.com/2023/03/the-good-bad-and-ugly-side-of-510ks-hpms-early-experience-with-the-estar-template-for-510ks/?utm%5Fsource=rss&utm%5Fmedium=rss&utm%5Fcampaign=the-good-bad-and-ugly-side-of-510ks-hpms-early-experience-with-the-estar-template-for-510ks) the eSTAR template is a structured interactive PDF that takes a user section-by-section and question-by-question through the 510(k) content. She shares these “early learnings”:

- don’t start preparing an eSTAR submission too early in the process because answers to early questions in the template cause various sections to appear or not appear;
- know your guidances because several eSTAR sections have questions that walk through related guidances and it is important to be familiar with the relevant guidances to answer the questions appropriately;
- performance testing summaries may no longer be needed since the only eSTAR requirements are complete test reports for the testing;
- the template performance testing section asks for the 510(k) number of a device “that is the best comparator for the testing,” not necessarily the predicate device;
- a specific eSTAR section for human factors documentation is not included;
- there appear to be some embedded labeling requirements that have not been previously seen, meaning that submitters should review all template questions to ensure specific labeling information is incorporated;
- there is an option to provide a 510(k) summary as an attachment or the submitter can enter summary information in fields throughout the template that will be used to auto-generate a 510(k) summary;
- for submission of a modification to an existing device, the template requires information for all sections, even if the content of the section is not affected by the change.