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  1. How to Study and Market Your Device

Update: March 29, 2024

eSTAR is now available for voluntary use for 513(g) requests for information to CDRH.

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 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). This requirement includes 510(k) combination products and Dual 510(k)/CLIA Waiver IVD submissions. eSTAR is voluntary for medical device De Novo submissions to CDRH or CBER. eSTAR is also voluntary for medical device PMA, Pre-Submissions (a type of Q-Submission), and 513(g) requests for information to CDRH.

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

  1. 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).

    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."

  2. Read, understand, and follow the directions in the Introduction, Key, FAQ, and Version History sections of the eSTAR PDF template.
  3. 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.

Current eSTAR Versions1:

eSTAR PDF Template1 (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 (nIVD) eSTAR Version 5 510(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 5 510(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 1 Pre-Submissions and 513(g) requests for information for Non-In Vitro and In Vitro Diagnostic devices.3 0910-0756, 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 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 only.

4 eSTAR can be used for voluntary submission of the following PMA application and supplement types to CDRH only: Original PMAs, PMA Panel Track Supplements (PTS), PMA Real-Time (RT) Supplements, and PMA 180 Day Supplements.

How to submit an eSTAR

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. De Novo, Pre-Sub submissions, certain PMA application and supplement types, and 513(g) requests for information can be voluntarily submitted as eSTARs through the CDRH Portal or mailed to the FDA.

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 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.

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, 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)."

A PMA will be reviewed according to 21 CFR part 814.

Is eSTAR voluntary?

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).

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 Windows versions. Mac Adobe Acrobat Pro is not affected. We are working with Adobe to help them resolve this bug. 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.

 

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