The eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. This template contains:

• Automation (for example, form construction and autofill)
• Content and structure that is complementary to FDA internal review templates
• Integration of multiple resources (for example, guidances and databases)
• Guided construction for each submission section
• Automatic verification

The eSTAR is free and available for voluntary use by all medical device applicants wishing to submit 510(k)s, De Novo requests, and Pre-Submissions to the Center for Devices and Radiological Health (CDRH), and medical device applicants wishing to submit 510(k)s to the Center for Biologics Evaluation and Research (CBER). The eSTAR is now available for use with combination products.

The voluntary 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.

Due to the use of automatic verification, the FDA does not intend to conduct a Refuse to Accept (RTA) review for submissions submitted as an eSTAR.

On this page:

• How to prepare a submission using eSTAR
• How to submit an eSTAR
• What is the CBER eSTAR Pilot?
• 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

1. 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."

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 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:

¹Minor 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.

²An 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.

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 [email protected].

How to submit an eSTAR

Online:

For CDRH, send eSTAR premarket submissions online through the CDRH Portal:

• Send and Track Medical Device Premarket Submissions Online: CDRH Portal

For CBER, send eSTAR premarket submissions online through the FDA’s Electronic Submission Gateway (ESG) method. Instructions available at:

• Regulated Submissions in Electronic and Paper Format for CBER-Regulated Products

By Mail:

Note: The FDA only intends to accept 510(k) submissions saved to a form of electronic storage media and mailed to the FDA if they are received by the FDA before October 1, 2023. For more information, see the guidance document, Electronic Submission Template for Medical Device 510(k) Submissions. De Novo submissions can continue to be sent as eCopies or eSTARs via either the CDRH Portal or mail couriers after October 1, 2023.

If you submit 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. Furthermore, “Additional Information” responses may be submitted as eCopies via mail couriers after Oct 1, 2023 for 510(k)s processed for review before October 1, 2023.

If you submit an invalid eCopy or your user fee is not paid, and neither of these are resolved for a new 510(k) by October 1, 2023, your submission and “Additional Information” responses will need to be converted to an eSTAR and submitted via the CDRH Portal for CDRH submissions or FDA’s ESG for CBER submissions to be processed for review.

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

Important: The eSTAR does not need to comply with the eCopy Guidance document and it does not need to be zipped and placed in a MISC FILES folder. Any additional files provided alongside the eSTAR PDF need to comply with the eCopy Guidance document, although we strongly recommend not providing additional files alongside the eSTAR PDF.

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.

CBER eSTAR Pilot

The Center for Biologics Evaluation and Research (CBER) pilot program is free and available for voluntary use by applicants of CBER premarket notification (510(k)) submissions that wish to use the voluntary eSTAR Program. CBER's voluntary eSTAR Pilot Program is intended to help applicants gain experience with the review of and internal processes for 510(k) submissions using the eSTAR template. It is also intended to help applicants gain experience with use of the FDA Electronic Submissions Gateway for CBER 510(k) submissions using the eSTAR template. During CBER's voluntary eSTAR Pilot Program, nine participants that meet the selection criteria outlined within the [Federal Register Notice] have the opportunity to participate in the eSTAR pilot program for submissions to CBER. This pilot will end on September 30, 2023.

To be considered for CBER's voluntary eSTAR Pilot Program, a company should submit a statement of interest for participation to [email protected] with the subject line: "CBER Voluntary eSTAR Pilot Program." Within the email, the company should:

• agree to submit a traditional, special, or abbreviated 510(k) for a medical device regulated by CBER using eSTAR within 1 month of acceptance to the CBER voluntary eSTAR Pilot Program.
• provide a detailed description of the device to allow CBER to verify that the device is a CBER-regulated device.
• have a willingness to provide feedback on eSTAR.

Participants selected for CBER's voluntary eSTAR Pilot Program should include the eSTAR PDF with embedded attachments and the cover letter in their submissions, and provide them to the FDA:

• electronically through the FDA Electronic Submissions Gateway (refer to "Electronic Submissions Gateway"), or
• by mail to the CBER Document Control Center (DCC) on a CD, DVD, or USB Drive (SD cards are not accepted). For the current mailing address for CBER's Document Control Center, see eCopy Program for Medical Device Submissions.

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 submission 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)."

Is eSTAR voluntary?

Yes, at this time, use of eSTAR is voluntary. However, starting October 1, 2023, all 510(k) submissions, unless exempted (as described in Section VI.A of the final guidance, Electronic Submission Template for Medical Device 510(k) Submissions), must be submitted as electronic submissions using eSTAR.

De Novo and Early Submission Requests (e.g. Pre-Submissions) submitted using eSTAR remain voluntary until further notice.

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 [email protected].

If you have questions regarding 510(k)s, De Novo requests, or Early Submission Requests for medical devices regulated by CDRH, please contact [email protected].

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 [email protected].

If you have any questions of submissions submitted to CBER through the ESG, please contact [email protected].

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, any version of Adobe Acrobat Pro 2017, and for at least some, but not all, users of Adobe Acrobat Pro DC and the latest Adobe Acrobat Pro Windows versions.  Mac Adobe Acrobat Pro DC 64-bit does not appear 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->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. Alternatively, if you are unable to switch applications and disabling Protected Mode does not resolve the Adobe bug, please contact: [email protected].