US FDA eSTAR - Expert Tips & Comprehensive Checklist for Successful Submissions

December 22, 2025

FDA submissions are a key milestone in making your innovation available to patients and confidence starts with the right preparation. FDA submissions can be simpler and less overwhelming than ever before! With the eSTAR template now mandatory for 510(k) and De Novo submissions effective October 1, 2025, as noted in the final guidance Electronic Submission Template for Medical Device De Novo Requests, the FDA has made electronic submissions simpler and more structured, the path to a smoother submission is clearer than ever. Here are practical tips to help you make the most of eSTAR Submissions, avoid common missteps, and download RegTrac eSTAR checklist to achieve a successful submission.

Always Start with the Latest eSTAR Template:

FDA updates eSTAR regularly to reflect new guidance, standards, and reviewer requirements. Submitting with the wrong version can result in Refuse-to-Accept (RTA) delays before the review even begins.

Tip: Always download the latest eSTAR directly from FDA’s website before starting a new submission. Open it in Adobe Acrobat Pro to have access to all the features required to complete the submission.

Set Up Your Primary Correspondent:

Decide and designate a main contact with the FDA, who would be the applicant/sponsor either manufacturer themselves or a consultant appointed by the applicant/sponsor. Only primary correspondent receives all FDA communications to ensure clarity and avoids confusion on communications.

Tip: If primary correspondent or correspondent/consultant is different from applicant/sponsor, the FDA regulator will correspond with this contact instead of applicant/sponsor contact.

Work Through Each Section Carefully:

The eSTAR template is designed to guide you in sequence, and certain answers will unlock hidden sections you’d otherwise miss, so ensure to proceed one step at a time. FDA reviewers expect every question to be addressed. Leaving a field blank is not acceptable.

Tip: If a section doesn’t apply, use “N/A – Not Applicable” and add a short explanation. For example, if your device is not sterile, clearly state why sterilization details are irrelevant. This shows reviewers you’ve considered every requirement and haven’t overlooked anything.

Consistency is Everything:

One of the most common reasons for FDA queries or Refuse to Accept (RTA) is inconsistency between informations/documents provided in the template for review. For example, a device dimension might be listed differently in the labeling than in the device description or the wording of indications for use may not match across the IFU, summary, and eSTAR text fields. Providing correct and consistent attachments saves time for the reviewer and helps avoid unnecessary delays.

Tip: Don’t Skip the “?” Instructions , every section in the eSTAR template includes built-in guidance marked with a “?” icon. These instructions are there for a reason and they explain what FDA expects in each section. Conduct an internal consistency audit before submission, cross-check all sections of the eSTAR against your technical documentation, labeling, and test reports, think of it as your checklist!

Use the Built-In Validation Tools:

A big advantage of eSTAR is its automated validation features. These checks are designed to catch common errors before submission like missing attachments, incomplete sections, incorrect formats.

Tip: Before submitting, confirm the status message at the top shows “STATUS: eSTAR Complete.”

Green/Red bars = mandatory fields
Gray bars = voluntary fields

In conclusion, with the FDA moving toward QMSR, the alignment with ISO 13485:2016 offers a golden opportunity for medical device manufacturers to simplify compliance, strengthen risk management, registrations in US & across the world and ensure product quality globally. Companies that proactively harmonize their QMS now will be better prepared for FDA inspections, ISO audits, and international market access.

At RegTrac, we help medical device manufacturers navigate QMSR and ISO 13485 compliance with confidence. From gap assessments and process alignment to audit readiness and risk management support, our experts ensure your quality systems are robust and globally aligned.

Ready to simplify compliance and strengthen your QMS? Book a meeting today and discuss how RegTrac can support your regulatory journey.