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FDA eSTAR Templates for a More Organized Submission Process

Preparing an FDA medical device submission rarely comes down to completing a single document. The challenge lies in performing the required development and regulatory activities and bringing the resulting regulatory, engineering, risk, testing, usability, cybersecurity, and quality information into a structure that is complete, consistent, and ready for review.

The FDA's electronic Submission Template and Resource, or eSTAR, provides an interactive PDF format that guides applicants through preparation of medical device submissions.

FDA requires 510(k) and De Novo submissions to be submitted using eSTAR unless an exemption applies. At Grassroots Dx, we provide practical regulatory resources designed to help medical device and software teams implement applicable requirements and generate supporting evidence throughout development, so submission preparation does not become a last-minute scramble.

What Does the FDA eSTAR Submission Process Require?

An FDA eSTAR template organizes submission information into defined sections and uses questions, prompts, and attachments to guide teams through the information expected for their submission type. FDA describes eSTAR as a standardized format designed to improve submission completeness and make information more accessible to applicants and reviewers.

That structure is useful, but the template cannot create the underlying evidence for you. Medical device teams still need to perform the appropriate development, risk management, testing, quality, software, cybersecurity, usability, and other applicable activities that generate the evidence supporting the submission.

Depending on the submission, this may involve device descriptions, labeling, risk information, performance data, software documentation, usability information, cybersecurity artifacts, verification and validation evidence, and other supporting documentation.

The eSTAR Template provides a structured format for organizing documentation and supporting information developed throughout the medical device lifecycle. The goal is to generate the required evidence as the medical device is developed rather than discovering missing activities or artifacts when the submission is being assembled.

Where Medical Device Teams Can Get Stuck

One common challenge is discovering development, testing or evidence gaps after the submission process is already underway. During submission preparation, medical device teams need to bring together technical documentation, risk management information, verification and validation evidence, software and cybersecurity artifacts, and other applicable supporting information in a clear and consistent way.

Software-focused medical devices or medical devices that include software can add another layer of complexity. When preparing what teams may refer to as a medical device eSTAR technical file, the focus should be on ensuring the underlying software development, cybersecurity, risk management, and testing activities have been performed and that the resulting evidence is available for the applicable eSTAR sections.

Teams can also run into trouble when responses within eSTAR do not accurately represent the medical device. FDA notes that inaccurate answers, including dropdown selections that cause later questions to be omitted, may result in an early hold during review. Preparing the required evidence and artifacts in advance can make it easier to complete eSTAR's structured questions and provide the necessary attachments.
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Simplify Your eSTAR Documentation Workflow

Our DIY regulatory resources are built to help medical device teams implement regulatory requirements and generate the supporting evidence needed for submission. Instead of reaching the submission stage and then determining what information needs to be assembled, you can use guided templates throughout development to establish a stronger regulatory and development framework.

An FDA eSTAR submission checklist can help your team review the applicable information and supporting attachments needed before working through the submission template. However, a checklist alone cannot replace the underlying development and regulatory activities required to generate those attachments.
DIY Regulatory Kits provide structured frameworks across key areas of medical device development, including quality management systems, clinical testing, risk management, usability, medical device software, and cybersecurity. The templates help teams implement applicable processes and activities while producing the documentation and evidence that can ultimately support FDA eSTAR and other regulatory submissions.

When using an eSTAR template for SaMD submissions, software teams should identify the documentation applicable to their medical device software and ensure that supporting information is organized for the relevant eSTAR sections. Our resources are not intended to replace the FDA's official eSTAR form. They provide structured frameworks, templates, training, and expert support to help teams perform applicable activities and prepare the technical documentation and artifacts that support the broader regulatory submission process.

Build Submission Readiness Into Your Development Process

A smoother submission process starts long before the final eSTAR file is prepared. When engineering, quality, regulatory, software, and product teams understand regulatory expectations early, they can perform the appropriate activities and generate stronger evidence as development progresses rather than attempting to reconstruct it later.

At Grassroots Dx, we developed DIY regulatory kits which combine customizable templates, SOAR® training, and expert guidance to help medical device teams navigate regulatory requirements while maintaining their development momentum.

Our QMS Regulatory Kit helps teams establish and implement an ISO 13485-based quality system. Our Software Regulatory Kit provides a structured framework for planning, designing, developing, mitigating risks, testing, and maintaining medical device software. Our Cybersecurity Regulatory Kit helps teams implement cybersecurity controls and activities and generate the supporting artifacts expected for regulatory submission.
Together, these resources are designed to help medical device teams build regulatory requirements into development, not simply document them at the end.

Our goal is to make regulatory knowledge more practical for the people doing the work. With guided resources and step-by-step support, your team can develop more robust, traceable regulatory evidence and approach eSTAR preparation with greater confidence.

Before submitting, always confirm that your team is working with the FDA's current eSTAR version, instructions, and requirements applicable to your submission.

Ready to build submission readiness into your development process? Explore our DIY Regulatory Kits and choose the framework that fits your medical device and regulatory needs.

Frequently asked questions

What is an FDA eSTAR Template?

An FDA eSTAR template is the FDA's interactive PDF-based electronic submission resource for preparing supported medical device premarket submissions. It uses structured questions and fields to guide applicants through applicable submission content.

What information belongs in an eSTAR Template?

The eSTAR template brings together administrative, device, regulatory, and supporting submission information. The exact content depends on the device, submission pathway, and responses entered into the template. Supporting information may include technical, risk management, software, cybersecurity, usability, performance, and other applicable evidence generated during medical device development.

What should an FDA eSTAR submission checklist cover?

An FDA eSTAR submission checklist should help medical device teams confirm that applicable submission information and supporting documentation are complete, consistent, current, and ready to be incorporated into eSTAR. It should also help identify whether required evidence or activities are missing before the submission is assembled.

How should teams organize a medical device eSTAR technical file?

A medical device eSTAR technical file should be organized around the documentation applicable to the device and submission pathway, with clear relationships between medical device requirements, risks, testing, and supporting evidence. The underlying evidence should be generated through the appropriate development and regulatory activities rather than created solely for submission.

Can software teams use an eSTAR template for SaMD preparation?

An eSTAR template for the SaMD preparation process can help medical device software teams organize applicable technical documentation and supporting artifacts for FDA submission. The underlying software evidence should be generated throughout the software development lifecycle through appropriate planning, design, development, risk mitigation, testing, traceability, and maintenance activities.

The specific submission requirements still depend on the medical device software and applicable regulatory pathway.

Does eSTAR replace design history file documentation?

No. eSTAR structures information for an FDA submission, while design and development documentation provides evidence of the activities performed to develop the medical device. Maintaining this evidence throughout development makes the applicable information and artifacts easier to incorporate into eSTAR when preparing the submission.

Which eSTAR version should a team use?

Teams should obtain the current version directly from FDA. The agency updates eSTAR periodically and publishes current versions and retirement information on its eSTAR Program page.

How can Grassroots Dx help with eSTAR preparation?

Grassroots Dx offers DIY QMS, Software, and Cybersecurity Regulatory Kits, customizable templates, SOAR® training, and expert support to help medical device teams implement regulatory requirements throughout development and generate the supporting evidence and artifacts needed for regulatory submission.

The kits complement the FDA eSTAR template by helping teams build the underlying regulatory and technical foundation that ultimately supports the submission.

Can the DIY Regulatory Kits support EU MDR technical documentation?

Yes. The Grassroots Dx DIY Regulatory Kits are designed to support both FDA and European regulatory requirements. The templates provide structured frameworks for implementing applicable quality, software, and cybersecurity requirements and generating the supporting documentation and evidence needed for EU MDR technical documentation.

For medical device software, the templates support software development lifecycle activities and applicable standards such as IEC 62304, while the QMS and Cybersecurity Regulatory Kits support applicable quality system and cybersecurity requirements. This allows teams to use the same underlying regulatory framework and development evidence to support both FDA submissions and EU MDR technical documentation, while addressing market-specific requirements where applicable.

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Practical regulatory kits, templates, training and other resources to help medical device teams prepare for submission.