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eSTAR Guidelines for Successful FDA Submissions

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All medical devices seeking to market into the US may require multiple submissions of various types to the Food and Drug Administration (FDA) throughout their lifecycle, this also includes submissions through the electronic Submission Template and Resource (eSTAR) system.

eSTAR Best Practices for Effective FDA Submissions

Each device, including software under the FDA, must be categorized based on its risk, intended use, indications, and novelty. This categorization process determines the route of conformity required for the device with the FDA and outlines any subsequent submissions necessary to maintain the conformity throughout its lifetime.  

Have questions on eSTAR FDA Submissions? Contact us today. 

The eSTAR system is an interactive PDF form that provides the applicant with guidance for the specific submission type being performed and was introduced on October 1, 2023. The use of the eSTAR system was intended to enhance the quality of the incoming submissions and to ensure that the data being provided is of good quality and consistency. It further allows the FDA to effectively and efficiently review premarket submissions and post-market submission types as well. 

The eSTAR system is free to use and is required for all 510(k) submissions for medical devices. It is also available for voluntary use with other submission types, such as premarket approval applications. Key benefits of using the eSTAR system include:

    • Guidance to the users assisting them with providing necessary information and data for their submission type 
    • Complimentary to the Submission Memo and Review Template (SMART) used by the reviewer during the review process ensuring the reviewer gets data as expected 
    • Standardized formatting making information more easily to identify and access during the submission and review process 
    • Submission automation making more efficient and eliminates the need to use the Refuse to Accept (RTA) function of the submission process as they do not need to conduct an RTA when eSTAR is used for the submission 
    • Data is auto filled after entering other locations in the submission required reducing discrepancies in information as submitted  
    • Built-in databases providing relevant information and guidance for the device based on the proper classification identification, auto-populates relevant standards information 
    • Forms are built-in to the eSTAR system (Truth & Accuracy statement, Form 3514, 510(k) Summary, Declaration of Conformity, and the Indications for Use Form 3881) 
    • Supports automation by structuring the submission data 

 

Before using eSTAR, it is recommended that the Electronic Submission Template for Medical Devices 510(k) Submissions Guidance be reviewed and understood prior to preparing your 510(k) submission. This guidance can be accessed here. 

Preparing and Navigating FDA Submissions with eSTAR

Below are the following steps in preparing and navigating eSTAR submissions. Adhering to these guidelines will help streamline the submission process and improve the efficiency of the FDA’s review.

1. Subscribe to Adobe Acrobat Pro as the eSTAR templates cannot be viewed using other PDF browsers and cannot achieve full functionality without the use of the Adobe Acrobat Pro software. 

2. Ensure to select and download the appropriate PDF template(s) for your submission type. All PDF template(s) for your submission types can be found here. The current templates available are: 

PDF FDA submissions with eSTAR

3. Read the directions as provided and ensure that you understand the information as provided. 

4. Complete the template according to the guidance provided for the submission type. 

Note: The templates are used to build the submission only. At the end of the PDF template there are submission instructions. The submission is setup in portals and the submission can only be 4 GBs and attachments cannot be larger than 1 GB. There are special instructions for submitting an attachment larger than the allotted size. All images and videos must be compressed prior to submission.  

Challenges and Pitfalls of eSTAR

After submitting through eSTAR, the submission status can be tracked. To read the full description, click here.

Although the use of eSTAR helps with ensuring accuracy and better submission data there are also negatives to using eSTAR. Some of the issues with eSTAR can include: 

    • Starting your submission too soon prior to preparing supporting documents and properly classifying the device 
    • Understanding and being familiar with the eSTAR templates prior to using them 
    • Ensuring what supporting evidence will be needed, including performance testing and use of non-clinical bench performance testing  
    • Identification of predicate devices or novelty of the device 
    • Not having human factors documentation to support submission 
    • Proper labeling such as handing on an aircraft labeling that is often missed 
    • Omission of sections in the template as omission is not allowed 

 

Navigating eSTAR FDA Submissions with MedEnvoy

It is recommended that you familiarize yourself with the eSTAR system and templates before use, ensuring that the classification and submission requirements for your device are fully understood. MedEnvoy can assist you in navigating eSTAR and ensuring a successful FDA submission. Should you require any support or have questions on eSTAR FDA Submissions, feel free to get in touch by clicking here.

Related Resources

This article is one of a series in which our key regulatory experts curated based on key findings at RAPS Convergence 2024. To read the full series, click here.

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