FDA eSTAR Electronic Submission Template: Complete Guide to 510(k) and De Novo Submissions
Comprehensive guide to the FDA eSTAR electronic submission template for 510(k) and De Novo submissions — mandatory requirements since October 2023, template structure, section-by-section walkthrough, completeness verification, submission methods, and common mistakes to avoid.
eSTAR Is Now Mandatory — and It Has Changed How 510(k) Submissions Work
Since October 1, 2023, the FDA requires that all 510(k) submissions — traditional, special, and abbreviated — be submitted electronically using the eSTAR (electronic Submission Template And Resource) template. Since October 1, 2025, De Novo classification requests are also mandatory via eSTAR. This represents the most significant change to FDA medical device submissions in over a decade.
The eSTAR is not simply a digital form. It is an interactive PDF with built-in logic, automated verification, embedded guidance, and structured data fields designed to standardize submissions, reduce incomplete applications, and accelerate the review process. This guide covers everything you need to know: which submissions require eSTAR, the template structure section-by-section, how to complete and submit it, and the common mistakes that cause submissions to be rejected at technical screening.
What Is eSTAR and Why Does It Exist
Background and Legislative Basis
The eSTAR program implements Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which requires electronic submissions for certain medical device applications. The FDA issued the final guidance "Electronic Submission Template for Medical Device 510(k) Submissions" on October 2, 2023 (originally issued September 22, 2022), establishing eSTAR as the mandatory format.
For De Novo submissions, the FDA issued the final guidance "Electronic Submission Template for Medical Device De Novo Requests" on August 23, 2024, with the mandatory use date of October 1, 2025.
Key Benefits of eSTAR
| Feature | Benefit |
|---|---|
| Automated completeness verification | Banner changes from red to green when all required fields are completed |
| Built-in guidance text | Help text and links to relevant FDA guidance documents embedded throughout |
| Structured data fields | Standardized format reduces ambiguity and inconsistency |
| Integrated attachment management | All supporting documents embedded in a single PDF file |
| Error checking | Automated validation catches missing information before submission |
| Standardized format | FDA reviewers can navigate submissions more efficiently |
Current Template Versions
| Template | Version | Application Types | OMB Numbers |
|---|---|---|---|
| Non-IVD eSTAR | Version 6.1 (v6.1, updated February 2026) | Traditional, Special, and Abbreviated 510(k); De Novo; PMA; voluntary IDE | 0910-0120, 0910-0844, 0910-0231 |
| IVD eSTAR | Version 6.1 (v6.1, updated February 2026) | Traditional, Special, and Abbreviated 510(k); De Novo for IVD devices; PMA | 0910-0120, 0910-0844, 0910-0231 |
| PreSTAR | Version 2 (v2, updated February 2026) | Pre-Submissions, IDE, and 513(g) requests for information | 0910-0756, 0910-0078, 0910-0511 |
The most recent updates (Version 6.1, effective February 2, 2026) align the eSTAR templates with the new Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference and replaces the former Quality System Regulation (QSR). On February 17, 2026, all three templates were further updated to include the FDA's updated Real-World Evidence (RWE) guidance (effective February 16, 2026). Version 6.0 (October 1, 2025) had previously enabled PMA 30-Day Notice supplement functionality, made De Novo use mandatory, and added Health Canada additional information response capabilities.
Which Submissions Require eSTAR
Mandatory eSTAR Submissions
| Submission Type | Mandatory Since | Submitting to |
|---|---|---|
| 510(k) — Traditional, Special, Abbreviated | October 1, 2023 | CDRH via CDRH Portal |
| 510(k) supplements and amendments | October 1, 2023 | CDRH via CDRH Portal |
| De Novo classification requests | October 1, 2025 | CDRH via CDRH Portal |
| CBER-regulated 510(k) and De Novo | Same dates | CBER via Electronic Submission Gateway (ESG) |
Voluntary eSTAR Submissions
The following submission types can be voluntarily submitted via eSTAR:
- Investigational Device Exemption (IDE) original and supplement submissions (available since September 2025)
- PMA 30-Day Notice supplement submissions
- Pre-Submissions (a type of Q-Submission)
- 513(g) requests for information
Exemptions from eSTAR Requirements
The FDA provides specific exemptions and waivers from the eSTAR requirement:
- Interactive review responses
- Amendments after final decision (add-to-files)
- Appeals and requests for supervisory review
- Substantive summary requests
- Change in correspondent amendments
- Submissions where known technical reasons prevent electronic submission via the CDRH Portal (these must be mailed to the CDRH Document Control Center)
Manufacturers who qualify for a waiver must request it from the FDA in advance of their submission.
eSTAR Template Structure: Section-by-Section Walkthrough
The eSTAR template is organized into the following major sections. Both the Non-IVD and IVD versions follow the same general structure, with IVD-specific additions where relevant.
Section 1: Submission Type and Administrative Information
This opening section captures the type of submission being made:
| Field | Description |
|---|---|
| Submission type | Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo |
| Cover letter | Upload cover letter (PDF) |
| Letters of reference | Upload any reference letters |
| Applicant information | Company name, address, contact person, phone, email |
| Pre-submission correspondence | List any prior Q-Submission or pre-submission interactions with FDA |
| Consensus standards | Identify any FDA-recognized consensus standards used in the submission |
Section 2: Device Description
This section requires comprehensive descriptive information about your device:
| Subsection | Requirements |
|---|---|
| Listing of devices | Product trade name and model number/name for each device |
| General device characteristics | Whether device is life-supporting or life-sustaining, prescription vs. OTC |
| Device description | Physical description, technological characteristics, materials, energy source, principle of operation, packaging |
| Proposed indications for use | Complete statement of intended use (now uses eSTAR model format instead of Form 3881) |
| Classification | Product code, classification regulation, classification panel, device class |
Key guidance: Use clear, plain language throughout. A company that used highly technical internal terminology in their device description received multiple FDA requests for clarification, adding 4 weeks to their review timeline.
Section 3: Predicate Devices and Substantial Equivalence
This is the core of any 510(k) submission — demonstrating that your device is substantially equivalent to a legally marketed predicate device:
| Field | Description |
|---|---|
| Predicate submission number | 510(k) number (K#), De Novo number (DEN#), or PMA number (P#) |
| Predicate device trade name | Commercial name of the predicate |
| Predicate product code | Primary product code with medical specialty and regulation |
| Substantial equivalence comparison | Detailed comparison table covering indications for use and technological characteristics |
| Technological characteristics comparison | Side-by-side comparison of design, materials, energy source, and other features |
| Discussion of differences | Explanation of why any differences do not raise different questions of safety and effectiveness |
The substantial equivalence comparison should be in tabular format and include both a comparison of indications for use and a comparison of the pertinent technological characteristics.
Section 4: Design/Special Controls, Risk to Health, and Mitigation Measures
This section is applicable primarily to Special 510(k) submissions:
| Field | Description |
|---|---|
| Device changes | Identification of the specific device changes being made |
| Risk analysis method | Description of the risk analysis method(s) used |
| Design controls | Summary of design verification and validation activities |
| Special controls | If the device is subject to special controls, evidence of how each is addressed |
Section 5: Design Verification and Validation
Verification and validation studies demonstrate that the device performs as intended:
| Subsection | Typical Content |
|---|---|
| Performance testing | Bench testing, engineering performance data |
| Biocompatibility | ISO 10993 biocompatibility evaluation results |
| Electrical safety | IEC 60601-1 series compliance data |
| Electromagnetic compatibility | IEC 60601-1-2 EMC test results |
| Software validation | Software documentation per IEC 62304, FDA software guidance |
| Sterility | Sterilization validation, packaging integrity |
| Human factors | Usability testing per IEC 62366 and FDA human factors guidance |
| Animal studies | If applicable, preclinical animal study data |
| Clinical data | Clinical study data if included (not required for all 510(k)s) |
The eSTAR template includes structured sections for uploading test results with clear guidance on required data formats.
Section 5b: Cybersecurity Documentation (Section Q)
For connected medical devices, the eSTAR includes a dedicated cybersecurity section (Section Q in the Non-IVD template). This section has become increasingly important since the FDA's June 2025 cybersecurity guidance, and deficiencies here are a leading cause of AI requests and RTA determinations.
| Cybersecurity Element | What Reviewers Expect |
|---|---|
| Software Bill of Materials (SBOM) | Complete list of all software components, libraries, and versions |
| Threat modeling | STRIDE or similar threat model covering the device's attack surface |
| Security architecture | Documentation of authentication, authorization, encryption, and secure communications |
| Vulnerability management | Plan for identifying, evaluating, and patching vulnerabilities post-market |
| Secure product development framework (SPDF) | Evidence that security was integrated throughout the development lifecycle |
| Configuration management | How security settings are managed and hardened |
| Event detection and logging | Audit trail and intrusion detection capabilities |
| Cryptographic implementation | Details of encryption algorithms, key management, and certificate handling |
Structure cybersecurity documentation with section headings that mirror the eight security categories from the FDA's June 2025 guidance: device identification, authorization, data protection, system integrity, malware protection, secure communications, security monitoring, and configuration management. Treat every item in Appendix 1 of that guidance as mandatory — reviewers flag omissions as deficiencies.
Section 6: Labeling
| Subsection | Requirements |
|---|---|
| Labels | Device label artwork |
| Instructions for use (IFU) | Complete IFU document |
| Patient labeling | Patient-facing materials if applicable |
| Predetermined Change Control Plan | PCCP documentation if applicable (new field added per PCCP policy clarifications) |
Section 7: Additional Information
This section handles amendments and additional information requests from FDA:
| Field | Description |
|---|---|
| Additional Information (AI) response | Structured format for responding to FDA requests |
| Deficiency responses | Itemized responses to specific deficiencies identified by FDA |
| Amendment tracking | Built-in tracking for multiple rounds of AI |
The Completeness Verification System
One of the most distinctive features of eSTAR is the automated completeness verification. The template's first-page banner operates as a traffic light system:
| Banner Color | Meaning |
|---|---|
| Red | Submission is incomplete — required fields are missing |
| Green | All required fields are completed — submission is ready for submission |
The FDA will not accept submissions with a red banner. This built-in quality check eliminates one of the most common reasons for 510(k) rejection: incomplete submissions.
Submission Methods
CDRH Submissions
For devices regulated by the Center for Devices and Radiological Health (CDRH):
- CDRH Portal (Client Collaboration Portal — CCP): The primary method for eSTAR submission. No physical media required. Upload the completed, green-banner PDF directly.
- CDRH Document Control Center (DCC): For submissions with known technical issues preventing portal submission. Mail the eSTAR on physical media.
CBER Submissions
For devices regulated by the Center for Biologics Evaluation and Research (CBER):
- Submit via the Electronic Submission Gateway (ESG)
- For 513(g) requests, can also be submitted through CBER's ESG
Joint Review Pilot (FDA + Health Canada)
The FDA and Health Canada operate a pilot program accepting eSTAR submissions for joint review. The program seeks device sponsors ready to submit an eSTAR to both agencies simultaneously. This can accelerate market access in both the US and Canada.
Common Mistakes and How to Avoid Them
| Mistake | Consequence | Prevention |
|---|---|---|
| Submitting with red banner (incomplete) | Automatic rejection at technical screening | Complete every required field; verify green banner before submission |
| Using proprietary terminology | AI requests adding weeks to review timeline | Use standard medical device terminology; include glossary if needed |
| Insufficient predicate comparison | FDA cannot determine substantial equivalence | Detailed tabular comparison covering all technological characteristics |
| Missing test reports | Refuse to accept (RTA) at acceptance review | Include all referenced test data in attachments |
| Ambiguous risk-benefit language | FDA safety concerns requiring extensive follow-up | Use clear, specific language; quantify claims where possible |
| Wrong template version | Submission processing delays | Download latest template from FDA website before each submission |
| Embedding non-PDF attachments | Validation errors | Ensure all attachments are in acceptable formats (PDF, images) |
| Submitting paper copies | Non-compliant submission | Use eSTAR exclusively for all mandatory submission types |
eSTAR vs. Traditional Paper Submissions
| Aspect | Traditional Paper/eCopy | eSTAR |
|---|---|---|
| Format | Unstructured PDF on CD/USB | Interactive PDF with built-in logic |
| Completeness check | Manual — reviewer discovers gaps | Automated — verified before submission |
| Guidance | External documents | Embedded in template |
| Submission method | Physical media to DCC | Electronic via CDRH Portal |
| Review efficiency | Variable — depends on organization | Standardized — faster reviewer navigation |
| Error rate | Higher — missing sections common | Lower — automated validation |
| Mandatory for 510(k) | No (pre-Oct 2023) | Yes (since Oct 1, 2023) |
| Mandatory for De Novo | No (pre-Oct 2025) | Yes (since Oct 1, 2025) |
How eSTAR Fits Into the Broader FDA Digital Strategy
The eSTAR program is one component of the FDA's broader digital transformation:
- eCopy Program: Required electronic copy format for all device submissions
- eSTAR: Structured templates for 510(k), De Novo, and expanding to other submission types
- CDRH Portal: Secure electronic submission gateway
- Digital Health Center of Excellence: Coordination of digital health device policy
- International harmonization: eSTAR supports IMDRF Regulated Product Submissions Working Group activities for global alignment
The FDA continues to expand eSTAR to additional submission types. IDE and PMA 30-Day Notice submissions became available for voluntary eSTAR submission in September 2025, and further expansion to full PMA submissions is expected.
Step-by-Step: Preparing Your eSTAR Submission
Step 1: Download the Correct Template
Visit the FDA eSTAR Program page and download the appropriate template:
- Non-IVD eSTAR for traditional medical devices
- IVD eSTAR for in vitro diagnostic devices
Step 2: Gather Required Documentation
Before starting the template, prepare:
- Device description and specifications
- Predicate device information (510(k) number, trade name)
- All test reports (bench, biocompatibility, EMC, software, etc.)
- Labeling (labels, IFU, patient labeling)
- Consensus standards referenced
- Pre-submission correspondence history
Step 3: Complete Each Section
Work through the template sections systematically. Use the embedded help text and links to FDA guidance documents. The template's built-in logic will show or hide sections based on your earlier answers.
Step 4: Upload Attachments
Embed all supporting documents within the eSTAR PDF. The template manages attachments internally — you do not submit separate files.
Step 5: Verify Completeness
Check that the banner has turned from red to green. Review every section to ensure accuracy.
Step 6: Save the Final PDF
Save the completed eSTAR as a flat PDF file. This is your submission document.
Step 7: Submit
Upload via the CDRH Portal (CCP) for CDRH-regulated devices, or via ESG for CBER-regulated devices.
Frequently Asked Questions
Can I use eSTAR for PMA submissions?
As of April 2026, eSTAR is not yet mandatory for PMA submissions. However, CBER is voluntarily accepting eSTAR for PMA submissions. The FDA is expected to expand mandatory eSTAR to PMA applications in the future. The eSTAR template already includes a PMA option in the submission type selection, though it is not currently selectable for CDRH submissions.
What happens if my eSTAR submission fails technical screening?
If your eSTAR fails technical screening, you will receive a notification explaining the deficiency. You must address the issues and resubmit the corrected eSTAR. Common reasons for technical screening failure include incomplete sections, missing attachments, and incorrect file formats.
Can I submit a paper 510(k) instead of using eSTAR?
No. Since October 1, 2023, all 510(k) submissions must be submitted electronically using eSTAR, unless you qualify for a specific exemption or have obtained a waiver from the FDA. The only exception is for submissions with known technical issues preventing portal submission, which must be mailed to the DCC.
Do I need special software to use eSTAR?
The eSTAR template is an interactive PDF that requires Adobe Acrobat (not Adobe Reader) for full functionality. Some users have reported issues with non-Adobe PDF viewers. Download the latest version of the template from the FDA website and use Adobe Acrobat to complete it.
How long does it take to complete an eSTAR?
For a well-prepared submission with all documentation ready, completing the eSTAR template typically takes 2-4 hours of data entry and formatting. However, gathering all the required supporting documentation can take weeks or months depending on the device complexity and the completeness of your design history file.
What is the difference between eSTAR and eCopy?
eCopy is the FDA's format requirement for electronic copies of submissions (PDF on CD or USB). eSTAR is a structured interactive template that replaces the traditional submission format. eSTAR submissions are submitted through the CDRH Portal or ESG, not as physical eCopy media.
Can international manufacturers use eSTAR?
Yes. The eSTAR template is available to any manufacturer worldwide who needs to submit a 510(k) or De Novo to the FDA. The FDA's eSTAR template has been updated with international help text models, and the Indications for Use section now uses the eSTAR model instead of Form 3881 to prepare for multi-jurisdictional submissions.
How do I handle additional information (AI) requests in eSTAR?
When the FDA sends an AI request, you respond using the Additional Information section within the eSTAR template. The template includes structured deficiency response text boxes for itemized responses. Do not submit AI responses as separate documents — they must be incorporated into the eSTAR.
Is there a fee for using eSTAR?
No. The eSTAR template is free to download from the FDA website. However, standard FDA user fees for 510(k) and De Novo submissions still apply. For FY2026, the standard 510(k) user fee is $26,067, with a reduced fee of $6,517 for small businesses (those with gross receipts or sales of $100 million or less).
What should I do if I find an error in the eSTAR template?
Report malfunctions or errors to eSubPilot@fda.hhs.gov for CDRH-regulated devices. The FDA regularly updates the template to fix bugs and add new features — check the FDA website for the latest version before each submission.