FDA Updates eSTAR Program: Human Factors Content Added and Expanded PreSTAR Functionality
The U.S. Food and Drug Administration (FDA) has released an update to its electronic Submission Template and Resource (eSTAR) program, effective June 1, 2026. The update introduces two notable changes that medical device manufacturers should be aware of when preparing future FDA submissions.
Human Factors Content Integrated into eSTAR
The FDA has updated both the Non-In Vitro Diagnostic (nIVD) and In Vitro Diagnostic (IVD) eSTAR templates to incorporate the content of the recently published Human Factors Content Guidance, issued on May 29, 2026, and becoming effective on August 1, 2026.
This means manufacturers preparing 510(k), De Novo, or PMA submissions through eSTAR will now encounter updated Human Factors-related questions and data requirements directly within the submission template.
For manufacturers, this change reinforces the FDA’s ongoing emphasis on usability engineering and user interaction risks. Companies developing devices with user interfaces, home-use applications, software-driven functions, or complex operating procedures should ensure that their Human Factors documentation aligns with the new guidance before submission.
Expanded Functionality for PreSTAR
The FDA has also expanded the Early Submission Requests eSTAR, known as PreSTAR, which is now available for voluntary use with additional Q-Submission types.
In addition to existing Pre-Submissions, IDEs, and 513(g) requests, manufacturers may now use PreSTAR for:
Submission Issue Requests
Informational Meetings
Study Risk Determinations
PMA Day 100 Meetings
Accessory Classification Requests
The updated PreSTAR Version 3.0 provides a more structured pathway for a broader range of interactions with the FDA during product development and regulatory planning.
New eSTAR Versions Available
The FDA has released:
nIVD eSTAR Version 7.0
IVD eSTAR Version 7.0
PreSTAR Version 3.0
Previous Version 6.2 templates for both nIVD and IVD submissions, as well as PreSTAR Version 2.2, will be retired on August 3, 2026.
Although the FDA states that retired versions will not automatically be rejected, manufacturers may receive additional information requests if their submission does not reflect changes incorporated into the latest version.
What Manufacturers Should Do
Manufacturers planning FDA submissions in the coming months should:
Review the new Human Factors Content Guidance and assess its impact on ongoing projects.
Download and begin using eSTAR Version 7.0 where possible.
Consider using PreSTAR Version 3.0 for early FDA interactions and Q-Submission activities.
Verify that internal submission preparation procedures reference the latest eSTAR versions before August 2026.
The update continues the FDA’s broader effort to standardize submission content, improve submission quality, and facilitate more efficient premarket reviews.
Source: FDA eSTAR Program Update, June 1, 2026.
