Scaling Beyond the eSTAR Chasm

Cross the eSTAR Chasm - Scale Submissions with Essenvia AI

playbook

Summary:

FDA eSTAR Initiative Streamlines
510(k) Submissions

Launched in 2023, eSTAR replaced the error-prone eCopy process with an interactive PDF template that improves structure, clarity, and completeness. It integrates FDA guidance, offers validation checks, and has reduced technical screening errors from 20.5% to 5.4% (per 2025 MDUFA V data).

Challenges Remain Despite eSTAR's Success

MedTech regulatory teams face hurdles with collaboration, traceability, training burdens, and form performance issues. A 2023 survey showed 78% of respondents had concerns, particularly around lack of access control and update delays.

Essenvia’s AI-Powered eSTAR Portal Solves
Critical Bottlenecks

Essenvia’s patented online eSTAR platform enables team collaboration where users can work on different sections simultaneously, direct PLM/eQMS integrations, automatic version updates, and error reduction—accelerating submission time by an average of 19 weeks.

Challenges Remain Despite eSTAR's Success

Strategic Value for Global and US Market Entry

As eSTAR becomes mandatory for more submission types and expands internationally (e.g., Health Canada), automation becomes essential. AI-driven submission processes offer a competitive edge by slashing time to market and freeing RA teams for strategic work.

Summary:

FDA eSTAR Initiative Streamlines
510(k) Submissions

Challenges Remain Despite eSTAR's Success

Essenvia’s AI-Powered eSTAR Portal Solves
Critical Bottlenecks

Challenges Remain Despite eSTAR's Success

Strategic Value for Global and US Market Entry

Essenvia allows collaborative authoring and simultaneous users on FDA eSTAR submissions

Transitioning your 510(k) submissions to eSTAR has never been easier with Essenvia’s eSTAR submission builder.

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Our eSTAR submission builder is patented and truly unique on the market.

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“By using Essenvia, we were able to complete and submit the FDA eSTAR application with ease. The platform enabled us to have multiple collagues working simoultaneously on the same submission facilitating the authoring, editing, and review process. We are thankful for the outstanding support provided by the Essenvia team”

Christine Jensen

VP of Regulatory Operations

“We completed and successfully submitted our first FDA eSTAR submission using Essenvia. Thanks to this Platform our team was able to work together in one single place at any time to author, edit, and review the submission. As a regulatory leader, i also love seeing the total progress of the submission and individual sections as it’s being prepared and completed.

Once the submission was ready in the Essenvia Platform, we were able to instantly publish into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)”

MARTA STEPIEN

VP of clinical, Regulatory and Quality Affairs

Integrate Essenvia with your PLM or eQMS to map and auto-update attachments.

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Easily adapt to eSTAR

It’s easy and intuitive to use Essenvia’s eSTAR builder. In no time, cross-functional teams within your organization will find it extremely efficient and be an invaluable tool for regulatory and submissions functions.

Here’s just a taste of what Essenvia can do for your company:

Provides an easy digital walkthrough of every step
Map your custom templates to eSTAR
Edit your eSTAR live with multiple stakeholders
Map and auto-update all attachments
Gives a one-click preview of the native eSTAR file

Learn more Essenvia’s resource-saving eSTAR platform

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