Navigating FDA eSTAR Submissions: Challenges and Solutions from BioBoston Consulting

As regulatory requirements for medical device submissions become more stringent, the FDA has introduced tools to streamline and improve submission quality. One such tool is the eSTAR submission template, developed by the FDA Center for Devices and Radiological Health (CDRH). While the eSTAR (electronic Submission Template and Resource) is designed to enhance submission quality and reduce review times, its implementation poses unique challenges—especially for MedTech manufacturers unfamiliar with the tool. 

At BioBoston Consulting, we specialize in helping medical device and diagnostics companies navigate complex regulatory landscapes, including the new requirements around FDA 510(k) and De Novo eSTAR submissions. 

 

What Is the eSTAR? 

Introduced as a voluntary pilot in 2020 and becoming mandatory for 510(k) submissions as of October 1, 2023, the eSTAR is a fillable, interactive PDF template. It guides medical device sponsors through the premarket submission process, automatically verifying compliance with FDA guidance documents and eliminating the need for a separate Refuse to Accept (RTA) review. 

There are two versions of the eSTAR template—one for in vitro diagnostic (IVD) devices and another for non-IVD medical devices. By streamlining submission structure and content, the eSTAR helps sponsors ensure their applications are comprehensive, complete, and easier for the FDA to review. 

 

Common Challenges with the eSTAR Process 

While the eSTAR tool has significant benefits, it introduces several practical challenges that device manufacturers must prepare for. Here is a breakdown of key issues and BioBoston Consulting’s recommended solutions: 

1. Slow System Performance

The form’s interactive logic can cause delays as it dynamically hides or shows sections based on user input. These interruptions can hinder workflow and extend preparation time. 

BioBoston Tip: Develop a systematic plan for completing sections and avoid switching between topics. Our team also offers eSTAR pre-planning templates to speed up internal data gathering. 

2. No Change Tracking

With multiple contributors often involved in preparing a submission, the lack of change tracking makes collaboration difficult. 

Solution: Designate a single team member as the eSTAR owner. BioBoston can support your internal team by offering centralized document management and version control, reducing duplication and errors. 

3. Lack of Section Numbering

eSTAR does not assign numbers to sections, which can create confusion when organizing attachments. Attachments appear in alphabetical order, complicating document review and referencing. 

Our Recommendation: Use a logical naming convention. For example: 

• A1 – Device Overview 

• B1 – User Manual 

• C1 – Cleaning Validation 

BioBoston Consulting can help you create a standardized attachment structure tailored to your device classification and submission type. 

4. Limited Attachment Flexibility

The template restricts where attachments can be uploaded. This becomes particularly challenging when submitting Additional Information (AI) responses, which may not have a predefined section. 

Our Strategy: We assist clients in mapping attachments to the most relevant existing section and provide a rationale for placement. When responding to FDA AI letters, BioBoston ensures your updated eSTAR is aligned with the agency’s expectations. 

 

Why Partner with BioBoston Consulting for Your eSTAR Submission? 

At BioBoston Consulting, we specialize in MedTech regulatory consulting and eSTAR submission strategy. Our team of former FDA reviewers, regulatory experts, and clinical consultants provides end-to-end support, ensuring your 510(k) or De Novo submission is complete, compliant, and ready for review. 

Key Benefits of Partnering with Us: 

• FDA eSTAR Expertise: We understand the nuances of eSTAR form logic and documentation requirements. 

• Faster Submission Turnaround: Avoid delays and rejections with a clean, complete first submission. 

• Cross-functional Alignment: We coordinate your internal teams and document workflows to align with FDA expectations. 

• Strategic Regulatory Guidance: From labeling to bench testing data, we ensure your submission tells a clear, defensible story. 

Whether you are submitting your first eSTAR or responding to FDA feedback, BioBoston Consulting provides the knowledge and tools to ensure success. 

 

Do not Let eSTAR Challenges Derail Your Submission 

The FDA’s shift toward eSTAR will soon be standard. Do not let format frustrations or documentation gaps delay your device approval. Whether you are preparing a 510(k), De Novo, or responding to FDA Additional Information (AI) requests, BioBoston Consulting is your strategic partner in regulatory success. 

👉 Contact BioBoston Consulting today to schedule a consultation with our FDA regulatory experts and start your next eSTAR submission with confidence. Let us help you turn complexity into clarity and accelerate your path to market.