FDA eSTAR Template - Download Free Official Templates

Non-IVD eSTAR v6 FDA eSTAR Template FDA Official

Template Type: Non-In Vitro Diagnostic FDA eSTAR template Version 6

For: Most non-diagnostic medical devices

Supports: 510(k) submissions, De Novo applications, and PMA (Premarket Approval) medical device submissions for Non-In Vitro Diagnostic devices

OMB Numbers: 0910-0120, 0910-0844, 0910-0231

Device Examples: Surgical instruments, orthopedic implants, cardiovascular devices, diagnostic imaging equipment, infusion pumps, patient monitoring devices, and other traditional medical devices that are not in-vitro diagnostics.

This is the most commonly used FDA eSTAR template, covering the majority of medical device submissions. The Non-IVD eSTAR v6 FDA eSTAR template includes all required sections for demonstrating substantial equivalence, device description, indications for use, and supporting documentation for non-diagnostic devices. This FDA eSTAR template may be used to submit to CDRH or CBER.

File Format: Interactive PDF (requires Adobe Acrobat)

Template Version: Version 6 (v6) - Current as of 2024

⚠️ Important: Always download the FDA eSTAR template directly from FDA.gov to ensure you have the latest version.

download Download Non-IVD eSTAR v6 PDF Template (Direct Link)

IVD eSTAR v6 FDA eSTAR Template FDA Official

Template Type: In-Vitro Diagnostic FDA eSTAR template Version 6

For: In-vitro diagnostic (IVD) devices

Supports: 510(k) submissions, De Novo applications, and PMA (Premarket Approval) medical device submissions for In Vitro Diagnostic devices

OMB Numbers: 0910-0120, 0910-0844, 0910-0231

Device Examples: Laboratory test systems, diagnostic test kits, reagents, analyzers, point-of-care testing devices, molecular diagnostic tests, immunoassays, and other in-vitro diagnostic products used to test samples taken from the human body.

Use this FDA eSTAR template if your device is an in-vitro diagnostic device. The IVD eSTAR v6 FDA eSTAR template includes specialized sections for analytical and clinical performance data, intended use statements specific to diagnostic devices, and validation studies required for IVD submissions. This FDA eSTAR template may be used to submit to CDRH or CBER.

File Format: Interactive PDF (requires Adobe Acrobat)

Template Version: Version 6 (v6) - Current as of 2024

⚠️ Important: Always download the FDA eSTAR template directly from FDA.gov to ensure you have the latest version.

download Download IVD eSTAR v6 PDF Template (Direct Link)

PreSTAR v2 FDA eSTAR Template (Early Submission Requests eSTAR) FDA Official

Template Type: Early Submission Requests FDA eSTAR template (PreSTAR) Version 2

For: Pre-submission activities and early-stage regulatory communications

Supports: Pre-Submissions, IDE (Investigational Device Exemptions), and 513(g) requests for information for Non-In Vitro and In Vitro Diagnostic devices

Use Cases: Pre-submission meetings with FDA, IDE applications for clinical investigations, 513(g) requests for device classification information, and other early-stage regulatory interactions before formal submission.

PreSTAR v2 is the FDA eSTAR template designed for pre-submission activities. Unlike the main FDA eSTAR templates used for formal submissions, PreSTAR helps structure your early-stage regulatory communications with the FDA, including questions about device classification, regulatory pathways, and study design feedback. This FDA eSTAR template may be used to submit to CDRH or CBER.

File Format: Interactive PDF (requires Adobe Acrobat)

Template Version: Version 2 (v2) - Current as of 2024

⚠️ Important: Always download the FDA eSTAR template directly from FDA.gov to ensure you have the latest version.

download Download PreSTAR v2 PDF Template (Direct Link)

1. Collaboration and Version Control Nightmares

The Problem: The FDA eSTAR template is a secure PDF that requires Adobe Acrobat Pro for editing, making simultaneous collaboration extremely difficult. Teams accustomed to cloud-based tools like Google Docs struggle with version control when working with the FDA eSTAR template.

Real-Life Experience: A medical device company had five team members reviewing different sections of the FDA eSTAR template simultaneously. Without proper version control, conflicting edits were made to the same sections, resulting in lost work and a 3-week delay. Multiple reviewers working on predicate comparison tables in the FDA eSTAR template overwrote each other's changes, forcing them to reconstruct entire sections from scratch.

Solution: Establish a clear workflow where only one person edits the FDA eSTAR template at a time. Use version control by appending editor initials and dates to filenames (e.g., submission_v1.0_AB_2025-01-15.pdf). Use instant messaging or project management tools for communication, and maintain a master change log outside the FDA eSTAR template PDF.

2. Difficulty Telling Your Device's Unique Story

The Problem: The structured FDA eSTAR template format can make it challenging to present unique aspects of your device that don't fit neatly into predefined sections. Reviewers may miss important context when working within the FDA eSTAR template structure.

Real-Life Experience: A company developing a novel orthopedic implant had unexpected biocompatibility test results that required explanation. The FDA eSTAR template format required specific answers without room for context, leading to FDA questions that could have been avoided with better narrative. The structured FDA eSTAR template format forced them to provide yes/no answers when nuanced explanations were needed, resulting in additional information requests (AIs) that delayed clearance by 2 months.

Solution: Utilize comment sections and attachments strategically within the FDA eSTAR template. Create a "Device-Specific Considerations" document that explains unique features, unexpected test results, or novel technologies. Reference this document clearly within the main FDA eSTAR template. Don't rely solely on dropdown menus and checkboxes - use narrative sections effectively in the FDA eSTAR template to tell your device's story.

3. Software Compatibility and Performance Issues

The Problem: The FDA eSTAR template requires Adobe Acrobat Pro for full functionality, and users report significant performance issues, especially with large submissions containing many attachments in the FDA eSTAR template.

Real-Life Experience: A regulatory team working on a complex IVD submission using the FDA eSTAR template experienced severe lag - each time they answered a question, the FDA eSTAR template form took 10-15 seconds to update. With hundreds of fields to complete in the FDA eSTAR template, this added hours of frustration. One team member's older computer crashed repeatedly when trying to embed large test reports in the FDA eSTAR template, causing data loss. The performance issues with the FDA eSTAR template were so severe that they had to purchase new hardware specifically for eSTAR work.

Solution: Ensure all team members have the latest version of Adobe Acrobat Pro (not just Reader) and systems that meet specifications for working with the FDA eSTAR template. Allocate 20-30% additional time in project timelines for software-related delays when using the FDA eSTAR template. Save work frequently (every 15-20 minutes) and maintain backup copies of your FDA eSTAR template. Consider working on sections in smaller chunks rather than trying to complete large sections at once.

4. Manual Entry Instead of Using Dropdown Menus

The Problem: The FDA eSTAR template includes dropdown menus for product codes, device classifications, and other standardized information. Manually typing this information in the FDA eSTAR template can cause the template to miss applicable guidance documents and special controls.

Real-Life Experience: A startup company manually entered their product code in the FDA eSTAR template instead of selecting from the dropdown menu. This caused the FDA eSTAR template to miss applicable special controls guidance documents that should have been referenced. The FDA reviewer flagged this as incomplete, resulting in an RTA hold. The company had to restart their submission timeline, losing 3 months and incurring additional consultant fees.

Solution: Always use the dropdown menus provided in the FDA eSTAR template - never manually type product codes, device classifications, or other standardized fields. The dropdowns in the FDA eSTAR template trigger automatic inclusion of relevant guidance documents. Implement a quality check where a second team member verifies all dropdown selections in the FDA eSTAR template before submission.

5. File Size and Attachment Management Disasters

The Problem: FDA eSTAR template submissions have a 4 GB file size limit. Improper management of attachments in the FDA eSTAR template can cause submissions to exceed limits or become unmanageable.

Real-Life Experience: A company submitted an FDA eSTAR template with uncompressed high-resolution images and videos embedded directly in test reports. The FDA eSTAR template submission exceeded 4 GB and was rejected at upload. They had to spend a week reformatting, compressing images, and combining related documents in the FDA eSTAR template. Another company embedded 200+ individual PDF files in their FDA eSTAR template instead of combining related documents, making the submission nearly impossible for reviewers to navigate efficiently.

Solution: Compress all images and videos before attaching to the FDA eSTAR template. Combine related documents into single PDF files with bookmarks and a table of contents. For example, combine all biocompatibility test reports into one PDF rather than submitting 10 separate files in the FDA eSTAR template. Use PDF optimization tools to reduce file sizes while maintaining quality. Test your final FDA eSTAR template file size before submission.

6. Not Using the RTA Checklist Before Submission

The Problem: Many submitters skip the Refuse to Accept (RTA) checklist review, leading to missing critical documents or information.

Real-Life Experience: A well-funded startup submitted their 510(k) without running through the RTA checklist. They missed required cybersecurity documentation for their software-containing device, resulting in an immediate RTA hold. The hold lasted 6 weeks while they prepared the missing documentation, pushing their expected clearance date significantly. The RTA could have been avoided with a 2-hour checklist review.

Solution: Use the appropriate RTA checklist for your submission type (510(k), De Novo, PMA) and review your submission against it line-by-line before submission. Have a second person perform an independent RTA check. Create your own internal checklist based on the RTA requirements and check off each item as you complete it.

7. Inconsistent Data Across Documents and Sections

The Problem: Misalignment of data across different sections or between the eSTAR and attached documents raises red flags and can lead to rejection.

Real-Life Experience: A company had different device names in the device description section versus the labeling section. The indications for use in the eSTAR didn't match the IFU exactly. The predicate comparison table referenced a 510(k) number that didn't match the predicate information section. These inconsistencies triggered multiple FDA questions and delayed review by 2 months. Reviewers flagged this as a quality concern, requiring extensive clarification.

Solution: Conduct cross-document quality checks before submission. Create a master data sheet with device name, indications for use, product codes, and predicate information - reference this single source of truth throughout. Use "Find and Replace" functions carefully to ensure consistency. Have one person responsible for maintaining consistency across all sections.

8. Overuse of Jargon and Ambiguous Language

The Problem: Excessive technical jargon or unclear language can obscure meaning and frustrate reviewers, leading to additional information requests.

Real-Life Experience: A company used highly technical internal terminology throughout their substantial equivalence narrative. FDA reviewers unfamiliar with the company's specific terminology requested clarification on multiple points. The company had to provide a glossary and rewrite several sections in clearer language, adding 4 weeks to the review timeline. In another case, ambiguous language in the risk-benefit analysis section led to concerns about device safety that required extensive follow-up.

Solution: Use clear, direct language aligned with regulatory expectations. Avoid company-specific acronyms and terminology. Write for FDA reviewers who may not be experts in your specific device type. Have someone outside your technical team review the language for clarity. Use FDA guidance documents as style guides for terminology.

9. Structural and Formatting Errors

The Problem: Non-compliance with FDA formatting requirements, incorrect section ordering, or improperly embedded attachments can lead to rejection or requests for rework.

Real-Life Experience: A company modified the eSTAR template structure, thinking they could reorganize sections for better flow. The FDA rejected the submission because it didn't match the expected format. Another company embedded attachments in the wrong sections, making it difficult for reviewers to find required documentation. Both had to completely rebuild their submissions, losing months of work.

Solution: Never modify the eSTAR template structure - only fill in the fields and attach documents in designated sections. Follow the template's exact order and organization. Ensure all attachments are properly embedded (not just linked) and appear in the correct sections. Review FDA formatting guidance documents before starting.

10. Reactive Rather Than Proactive Writing

The Problem: Waiting until all testing is complete before starting the eSTAR submission leads to disorganized documents, rushed writing, and missed requirements.

Real-Life Experience: A company waited until all testing was complete before opening the eSTAR template. They discovered requirements they hadn't anticipated, forcing them to conduct additional testing. The rushed writing led to inconsistencies and errors that required multiple rounds of corrections. What should have been a 6-month submission process took 12 months due to reactive planning.

Solution: Begin drafting regulatory documents early in the development process. Open the eSTAR template during device development to understand requirements before testing begins. Create a submission timeline that accounts for writing, review, and revision cycles. Start with sections that don't depend on final test results (device description, intended use) while testing is ongoing.

11. Using Outdated FDA eSTAR Template Versions

The Problem: The FDA periodically updates the FDA eSTAR template. Using an outdated FDA eSTAR template version can lead to missing required sections or compatibility issues.

Real-Life Experience: A company downloaded the FDA eSTAR template in early 2023 and worked on it for 8 months. When they submitted in late 2023, the FDA had updated to version 6, which included new cybersecurity sections. Their submission was rejected because it lacked required sections that didn't exist in the older FDA eSTAR template version. They had to rebuild their entire submission in the new FDA eSTAR template format.

Solution: Always download the latest FDA eSTAR template directly from FDA.gov immediately before starting your submission. Check for FDA eSTAR template updates monthly if your submission will take several months. Version 6 (v6) is current as of 2024 - verify you're using the latest FDA eSTAR template version.

12. Wrong FDA eSTAR Template Selection (Non-IVD vs IVD)

The Problem: Using the wrong FDA eSTAR template type (Non-IVD eSTAR for an IVD device or vice versa) causes structural issues and missing required sections.

Real-Life Experience: A company developing a point-of-care diagnostic test mistakenly used the Non-IVD FDA eSTAR template. Halfway through their submission, they realized their device was classified as IVD. The IVD FDA eSTAR template has different sections for analytical and clinical performance data that weren't in the Non-IVD FDA eSTAR template. They had to start over with the correct FDA eSTAR template, losing 3 months of work.

Solution: Carefully determine your device type before downloading any FDA eSTAR template. Review FDA device classification databases and guidance documents. If unsure, consider a Pre-Submission (Q-Sub) meeting using PreSTAR v2 to confirm device classification and appropriate FDA eSTAR template before investing time in the wrong format.