eSTAR Program
Update: February 2, 2026
The nIVD and IVD eSTARs now align with the new Quality Management System Regulation (QMSR) effective on February 2, 2026.
Update: September 30, 2025
As of October 1, 2025 all De Novo submissions must be submitted as electronic submissions using eSTAR, as noted in the final guidance, Electronic Submission Template for Medical Device De Novo Requests. Exemptions to this requirement are noted in Section VI.A “Waivers and Exemptions From Electronic Submission Requirements” of the guidance.
eSTAR is now available for voluntary use for Investigational Device Exemption (IDE) original and supplement submissions, as well as PMA 30-Day Notice supplement submissions.
CBER is voluntarily accepting eSTAR for medical device Premarket Approval Applications (PMA), Investigational Device Exemptions (IDE), and Pre-Submissions (a type of Q-Submission).
The electronic Submission Template And Resource (eSTAR) is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. eSTAR provides the following benefits:
- Guides the submitter to ensure they provide the necessary details for the submission.
- Complements the reviewers' internal Submission Memo And Review Template (SMART) used to review the submission (the questions correlate), so the reviewer is getting what is expected.
- Provides a standardized format to make information accessible for the reviewer and submitter.
- Automates many aspects of the submission to ensure the content is present, eliminating the need for a Refuse to Accept (RTA) review by the reviewer and RTA holds. The FDA does not intend to conduct an RTA review for an eSTAR submission.
- Auto fills entered information to avoid entering the same information twice.
- Includes built-in databases to ensure classification identification and standards information are auto filled accurately.
- Includes built-in forms (Truth & Accuracy statement, Form 3514, 510(k) Summary, Declaration of Conformity, and the Indications for Use Form 3881).
- Collects submission data in a structured format to help automate many aspects of FDA processing.
- Serves as a comprehensive resource to consolidate the necessary information and links needed for submission preparation.
eSTAR is free and is required for all medical device 510(k) and De Novo submissions, unless exempted, to the Center for Devices and Radiological Health (CDRH) or to the Center for Biologics Evaluation and Research (CBER). This requirement includes 510(k) and De Novo submissions for combination products sent to CDRH or CBER and Dual 510(k)/CLIA Waiver IVD submissions to CDRH. eSTAR is voluntary for medical device Premarket Approval Applications (PMA), Investigational Device Exemptions (IDE), Pre-Submissions (a type of Q-Submission), and 513(g) requests for information to CDRH or CBER.
eSTAR is intended to enhance the incoming quality of submissions for a wide range of medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review. With a standardized format, submitters can ensure their submissions are complete, and the FDA can conduct premarket reviews more efficiently to help promote timely access to safe, effective, and high-quality medical devices.
For simplicity, the electronic submission created with this electronic submission template is often referred to as an eSTAR.
On this page:
- How to prepare a submission using eSTAR
- How to submit an eSTAR
- What are the MDUFA User Fees associated with eSTAR submissions?
- What is the Review Timeline?
- Is eSTAR voluntary?
- Who do I contact if I have questions?
- More Information
How to prepare a submission using eSTAR
Download the proper eSTAR PDF template from the table below and save it before you open it in Adobe Acrobat Pro. eSTAR cannot be viewed in a web browser (for example, Microsoft Edge).
In Edge, Chrome, or Firefox: Right-click the link and select "Save Link As."
In Safari, press "control" + click the link and select "Download Linked File."
- Read, understand, and follow the directions in the Introduction, Key, FAQ, and Version History sections of the eSTAR PDF template.
- Fill in the template accordingly. The template is only used for constructing, not submitting, your submission. The directions at the end of the template provide instructions on how to submit.
File Size: The CDRH Portal cannot receive eSTARs that are larger than 4 GB total or have attachments larger than 1 GB. If your eSTAR is greater than 4 GB or you have an attachment larger than 1 GB, please refer to the CDRH Portal website for additional instructions on how to proceed. Submissions to CBER through the FDA Electronic Submission Gateway (ESG) are limited to 100 GB in size. Please ensure any attached images and videos are compressed in a Microsoft Windows compatible format viewable in native Windows OS applications or the VLC Media Player application (for example, JPEG, AVC MP4, HEVC MP4). We highly recommend using HEVC video compression for videos. Ultra-High-Definition videos should only be provided if high resolution is necessary to support the review of the device. Take care when determining the proper resolution to display features of interest in images and videos.
File Attachments: eSTAR accepts a wide range of attachment types and names. Unacceptable attachment types or names are automatically prevented with a popup explanation message. Attachments can be sorted in the attachment pane. Please combine attachments of similar content (for example, Software Requirements Specifications) when possible so that fewer attachments need to be provided for each attachment type question in the eSTAR. Attachments may be combined in Adobe Acrobat Pro by choosing "Tools" then "Combine Files" or by combining in a PDF Portfolio. We recommend that combined documents have bookmarks or contain a Table of Contents for easier review. In addition, we discourage submitting PDF attachments with any type of security setting (for example, password protection) as this affects our ability to redact Confidential Commercial Information efficiently.
Although it is not required for you to use Version 6.1 of the nIVD and IVD eSTARs if you are already using Version 6.0, PMA applicants that intend to submit Quality Management System (QMS) information should ensure their QMS documentation follows the content recommendations in the latest help text consistent with the FDA Quality Management System Regulation (QMSR). The FDA published amendments to 21 CFR 820 in 2024 in the Federal Register, with an effective date of February 2, 2026. The FDA provided interested parties with a two year transition period. If you submit QMS information on or after February 2, 2026 using a version of eSTAR from before Version 6.1, you may attach any “Planning of Product Realization and Customer Related Processes” documentation in the “Other Quality System Information” attachment question.
Current eSTAR Versions1:
| eSTAR PDF Template1 (you MUST download per instructions above) | This eSTAR template may be used to submit to CDRH or CBER: | Content is approved for collection under OMB numbers2: |
|---|---|---|
| Non-In Vitro Diagnostic (nIVD) eSTAR Version 6 | 510(k), De Novo, and PMA4: medical device submissions for Non-In Vitro Diagnostic devices | 0910-0120, 0910-0844, 0910-0231 |
| In Vitro Diagnostic (IVD) eSTAR Version 6 | 510(k), De Novo, and PMA medical device submissions for In Vitro Diagnostic devices | 0910-0120, 0910-0844, 0910-0231 |
| Early Submission Requests eSTAR (PreSTAR) Version 2 | Pre-Submissions, IDE, and 513(g) requests for information for Non-In Vitro and In Vitro Diagnostic devices.3 | 0910-0756, 0910-0078, 0910-0511 |
1 Minor version changes would not cause retirement of a prior eSTAR version. Therefore, only the major version numbers of eSTAR are reflected in the table above. Once you receive an acknowledgement letter for your submission, your submission is grandfathered in to that eSTAR version. You should always use the eSTAR with your latest information when responding to an Additional Information request.
2 An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless a currently valid OMB number is provided.
3 The third eSTAR, referred to as the PreSTAR, contains content for Early Submission Requests, including pre-submissions, IDEs, and 513(g) requests for information and is now available for voluntary use. It should be used for both nIVDs and IVDs submitted to CDRH or CBER. eSTAR is intended for submitting Original IDEs and Supplements, as well as their Amendments, but not IDE Reports.
4 eSTAR can be used for voluntary submission of the following PMA application and supplement types to CDRH or CBER: Original PMAs, PMA Panel Track Supplements (PTS), PMA Real-Time (RT) Supplements, PMA 180-Day Supplements, and 30-Day Notice/135-Day Supplements.
How to submit an eSTAR
All 510(k) submissions as of October 1, 2023, and De Novo submissions as of October 1, 2025, must be submitted as electronic submissions using eSTAR through the CDRH Portal for CDRH, or the Electronic Submission Gateway (ESG) for CBER, unless exempted. IDEs, Pre-Sub submissions, and certain PMA application and supplement types can be voluntarily submitted as eSTARs through the CDRH Portal or mailed to the FDA. 513(g) requests for information can be voluntarily submitted as eSTARs through the CDRH Portal, online through CBER’s ESG, or mailed to the FDA.
If you submitted a valid eCopy for a new De Novo submission and you paid the user fee before October 1, 2025, your De Novo submission will be processed for review. “Additional Information” responses may be submitted as eCopies or mailed to the FDA after October 1, 2025, for De Novo submissions processed for review before October 1, 2025.
If you submitted an invalid eCopy or your user fee was not paid, and these items were not resolved for a new De Novo by October 1, 2025, your submission and “Additional Information” responses must be converted to an eSTAR and submitted through the CDRH Portal for CDRH submissions or the ESG for CBER submissions to be processed for review.
You do not need to provide an "Indications for Use" page (Form FDA 3881), the "Premarket Review Submission Cover Sheet" (Form FDA 3514), or a "Declaration of Conformity" (if applicable) with your eSTAR since all are built into the eSTAR PDF. In addition, if you choose to use eSTAR to create your 510(k) Summary, you do not need to provide an additional 510(k) Summary with your eSTAR.
Online:
For CDRH, send eSTAR premarket submissions online through the CDRH Portal:
For CBER, send eSTAR premarket submissions online through the FDA's Electronic Submission Gateway (ESG) method. Instructions available at:
By Mail:
eSTARs submitted by mail to CDRH's Document Control Center (DCC) should be sent to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
eSTARs submitted by mail to CBER's Document Control Center (DCC) should be sent to:
U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue - WO71, G112
Silver Spring, MD 20993-0002
After you complete your eSTAR submission correctly, the status message at the top will indicate "eSTAR Complete." If you submit your eSTAR submission while the status message still indicates "eSTAR Incomplete," the FDA will put your eSTAR on hold and notify you via email. The email will include a screenshot of the "Verification" section of the eSTAR that lists the incomplete sections in the submitted eSTAR. Please be advised that the benefits of eSTAR (for example, no RTA review) are dependent on accurate responses and the FDA intends to verify the accuracy of your responses. Inaccurate responses (for example, inaccurate responses to drop down fields causing the eSTAR to omit subsequent questions) may lead to an early hold in the review of your submission.
What are the MDUFA User Fees associated with eSTAR submissions?
eSTAR submissions are subject to the user fees associated with the submission type (such as 510(k)). For the current user fee amounts, please see MDUFA User Fees.
What is the Review Timeline?
After the FDA receives an eSTAR submission, given that an electronic submission properly prepared with an electronic submission template should represent a complete submission, eSTAR submissions are not anticipated to undergo a refuse to accept (RTA) process. However, the FDA intends to employ a virus scanning and technical screening process for an eSTAR.
If the eSTAR does not pass technical screening (i.e., an eSTAR is provided where none of the attachments to a question are relevant to the question, or if an inaccurate response is provided to any question), the submission may be put on an early Technical Screening hold for 180 days, until a complete replacement eSTAR is submitted.
If an eSTAR provided by mail is not complete when submitted, the FDA will notify the submitter by email and identify the incomplete information, and the submission will be placed and remain on hold for 180 days or until a complete replacement eSTAR is submitted to the FDA.
For more information, see Electronic Submission Template for Medical Device 510(k) Submissions and Electronic Submission Template for Medical Device De Novo Requests.
Is eSTAR voluntary?
At this time, the use of eSTAR is voluntary for all submission types other than 510(k) and De Novo. A table summarizing electronic submission requirements by submission type is located on the eCopy Medical Device Submissions web page.
Any 510(k)s submitted after October 1, 2023, must be submitted as electronic submissions using eSTAR (as described in Section VI.A of the final guidance, Electronic Submission Template for Medical Device 510(k) Submissions).
Any De Novos submitted after October 1, 2025, must be submitted as electronic submissions using eSTAR (as described in Section VI.A of the final guidance, Electronic Submission Template for Medical Device De Novo Requests).
Who do I contact if I have questions?
If you have questions or feedback regarding the voluntary use of the eSTAR for medical devices regulated by CDRH, or if you have general questions about medical devices, please contact the Division of Industry and Consumer Education (DICE).
If you find any malfunctions or errors in the eSTAR template for medical devices regulated by CDRH, please contact eSubPilot@fda.hhs.gov.
If you have questions regarding 510(k)s, De Novo requests, or Early Submission Requests for medical devices regulated by CDRH, please contact OPEQSubmissionSupport@fda.hhs.gov.
If you have questions or feedback regarding CBER's voluntary eSTAR Pilot Program, an eSTAR PDF submitted to CBER, or if you have general questions about medical devices submitted to CBER, please contact the CBER Manufacturers Assistance and Technical Training Branch (MATTB) by email at Industry.biologics@fda.hhs.gov.
If you have any questions of submissions submitted to CBER through the ESG, please contact ESUBPREP@fda.hhs.gov.
More Information
Slowness in certain Adobe Acrobat Pro applications
Note: There is a JavaScript bug in certain Adobe Acrobat Pro applications that causes dynamic PDFs that use JavaScript in their functionality, like eSTAR, to run slower than normal. This slowness bug is not present in FoxIt PDF Reader, PDF-XChange Editor, any version of Adobe Acrobat Pro 2017, and for at least some, but not all, users of the latest Adobe Acrobat Pro versions. Until it is resolved we recommend you either: 1) disable Protected Mode by going to Edit (or Menu)->Preferences->Security (Enhanced) and uncheck the "Enable Protected Mode" checkbox at the top, which should resolve the Adobe bug for most, or 2) switch to one of the unaffected applications provided above. We also found that using the 64-bit version of Adobe Acrobat Pro helps resolve the slowness. Alternatively, if you are unable to switch applications and disabling Protected Mode does not resolve the Adobe bug, please contact: eSubPilot@fda.hhs.gov.