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  3. Device Advice: Comprehensive Regulatory Assistance
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  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. Premarket Notification 510(k)
  7. Voluntary eSTAR Program
  1. Premarket Notification 510(k)

Voluntary eSTAR Program

 

Person using eSTAR to guide them through maze of medical device submissions.

 

For more information on requirements for electronic submissions, see the FDA’s guidance document, “Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act”. The Agency has concluded that it is not feasible to describe and implement the electronic submission templates that would apply to all the submissions covered by section 745A(b)(3) in one guidance document. Accordingly, individual guidances will be developed to specify the formats for specific submission types and corresponding timetables for implementation.

In February 2020, to support the transition of premarket notifications [510(k)] submissions being provided solely in electronic format, CDRH developed and piloted the use of the electronic Submission Template And Resource (eSTAR). On September 8, 2020, CDRH expanded the use of the eSTAR to all 510(k) applicants that were not submitting combination products. Subsequently, to move towards consistent implementation of Section 745A(b) for 510(k)s, on September 29, 2021, the FDA issued a draft guidance: Electronic Submission Template for Medical Device 510(k) Submissions. The draft guidance outlines the structure, format, and use of the eSTAR for preparing electronic 510(k) submissions. This draft guidance is open for public comments until November 29, 2021, under docket number FDA-2021-D-0872. When finalized, the guidance will represent the current thinking of the FDA on this topic and require the electronic submission of 510(k)s in accordance with the corresponding timetable identified in the final guidance. 

In further support of transitioning to utilization of electronic formats for other types of marketing submissions, CDRH has also added the ability to prepare De Novo requests in the eSTAR. At this time, the De Novo content in the eSTAR, consistent with the De Novo final rule which published on October 5, 2021, is being provided for viewing purposes so applicants can review and become familiar with the content and compile a De Novo request for submission to CDRH. Voluntary eSTAR De Novo requests can be submitted to the FDA on or after January 3, 2022, which is the effective date of the De Novo final rule which published on October 5, 2021. It is anticipated that the next draft guidance on the content of the eSTAR for a specific submission type will be for De Novo requests.

The eSTAR is an interactive PDF form that guides submitters 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 CDRH internal review templates;
  • Integration of multiple resources (for example, guidances and databases);
  • Guided construction for each submission section; and
  • Automatic verification.

The eSTAR is free and available for voluntary use for all medical device submitters for 510(k)s submitted to CDRH. On January 3, 2022, the eSTAR can also be used for voluntary submission of De Novo requests to CDRH. The eSTAR is not currently for use for submissions for 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 the CDRH’s premarket review. With a standardized format, submitters can ensure their submissions are complete, and CDRH can conduct premarket reviews more efficiently to help promote timely access to safe, effective, and high-quality medical devices. Due to the use of automatic verification, the CDRH 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

  1. Download the proper eSTAR PDF template. Be sure to save the document on your computer by right clicking the link, (or pressing "control" + clicking on a Mac) and choosing “Save Link As/Download Linked File”, before you open it in Adobe Acrobat Pro and begin entering in data.

Note: This template is only used for constructing, not submitting, your submission. The directions at the end of the template provide instructions on how to submit.

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

Note About File Size: Processing of the submission may be delayed if the eSTAR PDF exceeds 1 GB in size. Please ensure any attached images and videos are compressed in a Microsoft Windows compatible format viewable in native Windows OS applications (for example, JPEG, MP4). 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.

Note About 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. We recommend that combined documents have bookmarks or contain a Table of Contents for easier information search.

Version 1:

The updates included in Version 1 of the eSTAR include the following attributes:

  • Minor updates for eSTAR 510(k)s to provide additional instructions and clarifications to submitters. Changes can be found in the “Version History” section on page one of eSTAR.
  • Previous eSTAR versions (for example, nIVD eSTAR Version 0.7 and IVD eSTAR Version 0.3) may continue to be submitted for any 510(k)s currently in draft form, since no major changes were made to the 510(k) content in Version 1 of eSTAR. Please use Version 1 when preparing new 510(k)s.
  • Inclusion of new capabilities and attributes which incorporate De Novo content consistent with the De Novo final rule which published on October 5, 2021.
  • Note: The De Novo policies in eSTAR Version 1 reflect those which will go into effect on January 3, 2022 as a result of the De Novo final rule. Do not use the eSTAR if you intend to submit a De Novo request before January 3, 2022, as it is intended only for preparing De Novo requests for submission on or after January 3, 2022 which is the implementation date stated in the De Novo final rule that published on October 5, 2021.
eSTAR PDF Template (right-click to download) This eSTAR template may be used to submit to CDRH: Content is approved for collection under OMB numbers1:
Non-In Vitro Diagnostic eSTAR Version 1 510(k) and De Novo medical device applications for Non-In Vitro Diagnostic devices 510(k): 0910-0120
In Vitro Diagnostic eSTAR Version 1 510(k) and De Novo medical device applications for In Vitro Diagnostic devices 510(k): 0910-0120
Note: The De Novo policies in eSTAR Version 1 reflect those which will go into effect on January 3, 2022 as a result of the De Novo final rule. Do not use eSTAR if you intend to submit a De Novo request before January 3, 2022, as it is intended only for preparing De Novo requests for submission on or after January 3, 2022.

1An 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.

Definitions:

eCopy: An electronic copy is a submission created and submitted on a compact disc (CD), Digital Versatile Disc (DVD), or flash drive and mailed to the FDA, and which is a duplicate of the previously required paper copy sent to FDA. An eCopy is not considered an eSubmission.

Electronic Submission template: A guided submission preparation tool for industry. An electronic submission template walks industry through the relevant contents and components for the respective premarket submission type and device to facilitate submission preparation and enhance consistency, quality, and efficiency in the premarket review process.

eSTAR (electronic Submission Template And Resource): An electronic submission template built within a structured dynamic PDF that guides a user through construction of an eSubmission. The eSTAR is the only type of electronic submission template that is currently available to facilitate the preparation of eSubmissions. For simplicity, the electronic submission created with this electronic submission template is often referred to as an eSTAR.

How to submit an eSTAR

Your submission should include:

  • The eSTAR PDF with embedded attachments on a CD, DVD, or USB Drive (SD cards are not accepted).
  • A printed cover letter to the Document Control Center (DCC). For the current mailing address for CDRH's Document Control Center, see eCopy Program for Medical Device Submissions.

For example, an acceptable submission package would consist of a printed cover letter accompanying a USB drive containing the eSTAR PDF.

Important: The eSTAR does not need to comply with the eCopy Guidance document. In addition, the eSTAR PDF 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.

After you complete your eSTAR file correctly, the status message at the top will indicate "eSTAR Complete." If you submit your eSTAR file 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 the 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.

How to submit responses to requests for additional information

Revise your original eSTAR and indicate in the "Application/Submission Type" section of the eSTAR that the Application Sub-Type is a response to a request for additional information. After you indicate the intent to provide a response to a request for additional information from the FDA, an additional section will appear near the end of the eSTAR where you can provide responses to requests for additional information.

What are the eSTAR Program MDUFA User Fees?

The eSTAR submissions are subject to user fees. For the current User Fee amounts, please see MDUFA User Fees.

What is CDRH Review and the Review Timeline?

After the FDA receives an eSTAR-prepared submission, the FDA does not intend to conduct the RTA process. 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. After January 3, 2022, a De Novo review will be conducted according to the FDA guidance, “De Novo Classification Process (Evaluation of Automatic Class III Designation),” following the procedures identified in 21 CFR 860, subpart D.

Whom do I contact if I have questions?

Please contact the Division of Industry and Consumer Education (DICE) by email at [email protected], or by phone at (800) 638-2041, or (301) 796-7100, if you have questions or feedback regarding the use of the eSTAR, or if you have general questions about medical devices.

Please contact [email protected] if you find any malfunctions or errors in the eSTAR template.

If you have questions regarding 510(k)s or De Novos, please contact [email protected].

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