Update: October 2, 2023
As of October 1, 2023 all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR, as noted in the final guidance: Electronic Submission Template for Medical Device 510(k) Submissions.
eSTAR is the only available electronic submission template to prepare 510(k) electronic submissions.
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 the information relevant for device specific guidances, 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) submissions, unless exempted, to the Center for Devices and Radiological Health (CDRH) or to the Center for Biologics Evaluation and Research (CBER). eSTAR is voluntary for medical device De Novo submissions to CDRH or CBER. eSTAR is also voluntary for medical device Pre-Submissions to CDRH. eSTAR can also be used for combination products and Dual 510(k)/CLIA Waiver IVD submissions.
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
Download the proper eSTAR PDF template from the table below and save it before you open it in Adobe Acrobat Pro.
Using Windows: In Microsoft Edge, right-click the link and select "Save Link As."
Using Mac OS: 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 Count: Please combine attachments of similar content (for example, Software Requirements Specifications) when possible so that only one attachment needs to be provided to each attachment type question in the eSTAR. Attachments may be combined in Adobe Acrobat Pro by choosing "Tools" then "Combine Files." We recommend that combined documents have bookmarks or contain a Table of Contents for easier review.
Current eSTAR Versions1:
|eSTAR PDF Template (you MUST right-click and download)||This eSTAR template may be used to submit to CDRH:||Content is approved for collection under OMB numbers2:|
|Non-In Vitro Diagnostic eSTAR Version 4||510(k) and De Novo medical device submissions for Non-In Vitro Diagnostic devices||0910-0120, 0910-0844|
|In Vitro Diagnostics eSTAR Version 4||510(k) and De Novo medical device submissions for In Vitro Diagnostic devices||0910-0120, 0910-0844|
|Early Submission Requests eSTAR (PreSTAR) Beta Version||Pre-Submissions (a type of Q-Submission) for Non-In Vitro and In Vitro Diagnostic devices.3||0910-0756|
3The third and final eSTAR, referred to as the PreSTAR, contains content for Early Submission Requests and is now available for use. It should be used for both nIVDs and IVDs submitted to CDRH only, and currently only contains Pre-Submission content. The PreSTAR was not piloted or tested outside of the FDA and is considered a beta version with no known bugs. If you have feedback, or find malfunctions or errors, please contact eSubPilot@fda.hhs.gov.
As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR through the CDRH Portal for CDRH or the Electronic Submission Gateway (ESG) for CBER. The FDA only intends to accept 510(k) submissions sent via mail couriers and 510(k)s sent as eCopies if they were received by the FDA before October 1,2023. De Novo and Pre-Sub submissions can continue to be sent as eCopies or eSTARs through the CDRH Portal or mailed to the FDA after October 1, 2023.
If you submitted a valid eCopy for a new 510(k) and you paid the user fee before October 1, 2023, your 510(k) will be processed for review. “Additional Information” responses may be submitted as eCopies or mailed to the FDA after October 1, 2023, for 510(k)s processed for review before October 1, 2023.
If you submitted an invalid eCopy or your user fee was not paid, and these items were not resolved for a new 510(k) by October 1, 2023, 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.
The eSTAR does not need to comply with the standards of the eCopy Guidance document and it does not need to be zipped and placed in a MISC FILES folder. Any additional files provided alongside an eSTAR PDF that is provided via mail couriers on media need to comply with the standards of the eCopy Guidance document, although we strongly recommend not providing additional files alongside the eSTAR PDF.
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:
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 intends to use the eCopy Hold process to put your eSTAR on "eCopy Hold." The "eCopy Hold" 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.
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.
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, 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.
The remainder of a 510(k) review will be conducted according to the FDA guidance, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," following the procedures identified in 21 CFR 807 subpart E.
A De Novo classification request will be reviewed according to 21 CFR part 860 subpart D, and as described in the FDA guidance, "De Novo Classification Process (Evaluation of Automatic Class III Designation)."
At this time, the use of eSTAR is voluntary for all submission types other than 510(k). 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).
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.firstname.lastname@example.org.
If you have any questions of submissions submitted to CBER through the ESG, please contact ESUBPREP@fda.hhs.gov.
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