Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx

What is the FDA’s electronic Submission Template and Resource (eSTAR) Program?

The eSTAR program, which stands for Electronic Submission, Tracking, and Reporting, initially focuses on the 510(k) pathway for medical device clearance, including software-based devices. Traditionally, the review process involved extensive paperwork and possible rejection for issues in documentation, formatting, and other compliance related challenges. The eSTAR program provides an editable pdf document that allows users to enter information and ensure compliance with different submission guidances.

Is the FDA eSTAR program mandatory in 2023?

Regulated software development, particularly in the healthcare industry, poses unique challenges due to stringent compliance requirements and time-consuming review processes. Recognizing the productivity losses associated with traditional review methods, the Food and Drug Administration (FDA) recently made the eSTAR program mandatory starting October 1, 2023¹.

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This initiative aims to revolutionize the regulatory landscape by streamlining the review process for software-based medical devices. In short, the eSTAR program aims to enhance productivity in regulated software development and enable the agency to provide faster feedback and approvals on submissions. For start-ups and younger companies, this program makes things simpler with a clear guide for submissions. For established companies that weren’t previously using eStar, it means change is now required.

eStar Documentation Level Changes in 2023

The eStar Program has recently intensified its documentation requirements, reflective of the FDA's heightened seriousness about comprehensive evidence submission. Notably, the FDA simplified their distinction for required software documentation from a 3-tiered to a 2-tiered level, based on the device risk level. No device software is considered “minor” going forward. Software developers whose device was previously categorized as “minor” will need to take a close look at the new requirements for their software documentation. Instead, the new guidance categorizes software documentation as either basic or enhanced to guide manufacturers on what to submit. In a recent webinar², the FDA made it clear that a risk analysis is the determining factor for the assigned documentation levels.

• Enhanced: If the failure or flaw of device software can result in death or serious injury, a comprehensive package of design control process artifacts are required. Device software formerly labeled as a major level of concern (LOC) falls under this category. 
• Basic: Requires a subset of the documentation required for devices meeting an enhanced determination. Devices with a previous Minor or Moderate³ level of concern (LOC) determination now fall into this category. 

In conjunction with this Documentation Level change,  the FDA has transitioned to an explicit line-by-line listing of mandatory attachments corresponding to internationally recognized design control process artifacts. This meticulous list includes the Software/Firmware Description, Risk Management File (inclusive of Hazard Analysis), Software Requirements Specifications (SRS), System and Software Architecture Design Chart, Software Design Specifications (SDS), and several more as shown in the screenshot below.

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The revamped procedure for submitting device software development documentation offers a step-by-step process ensuring that all requisite documentation is provided..

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Final thoughts on being eStar compliant

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At Ketryx, we believe that developers should be free to work with whatever development tools they want to use. They are the lifeblood of software development and responsible for the rapid advancement we’re seeing in medical devices. Therefore, we built a connected lifecycle management tool to eliminate process deviation and automate evidence generation. With Ketryx, product managers and developers can continue to use Jira, Github, or any other tools they want and rest assured that Ketryx will be documenting everything in the background and enforcing their standard operating procedures.

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Below you’ll note that everything required in the FDA eStar submission is automatically generated by Ketryx and easily accessible in the Design History module. 

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Footnotes:

1. Center for Devices and Radiological Health, “Voluntary Estar Program,” U.S. Food and Drug Administration, June 9, 2023, https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program.
2. US Food & Drug Administration. “Webinar Content of Premarket Submissions for Device Software Functions,” U.S. Food and Drug Administration, July 20, 2023, https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-content-premarket-submissions-device-software-functions-07202023#summary.
3. Moderate may fall into Enhanced or Basic as determined by risk analysis.

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