top of page
Aerial View of Waves

Streamlining Medical Device Submissions with eSTAR Program

 

Starting October 1, 2023, all 510(k) submissions (unless exempted) must be submitted using eSTAR. Pre-Market Notification (Pre-Subs), De Novo 510(k)s, and Pre-Market Approvals (PMAs) Early Submission are being piloted but eSTAR submission remains voluntary.  

 

https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program

 

The Food and Drug Administration (FDA) has introduced the Electronic Submission Template and Resource, or eSTAR program to enhance the efficiency of medical device submissions in a digital format. The eSTAR initiative will become the central platform for future FDA submissions and should help to improve manufacturers processes for preparing and submitting their applications for clearance or approval through a standardized and user-friendly portal. 

 

What is eSTAR? 

 

eSTAR is an interactive PDF form designed to guide applicants through the process of preparing a comprehensive medical device submission. The program offers several benefits, including:

 

  • Automation: eSTAR streamlines the form construction process and offers autofill features to save time and reduce errors.

  • Structured Content: It provides a structured format that aligns with FDA internal review templates, ensuring submissions are well-organized.

  • Integration: eSTAR incorporates various resources such as guidance documents and databases to facilitate the submission process.

  • Guided Construction: The program leads applicants through each submission section, minimizing confusion and ensuring completeness.

  • Automatic Verification: eSTAR employs automatic verification, reducing the need for a Refuse to Accept (RTA) review.

 

Why Choose eSTAR?  The voluntary eSTAR program offers several advantages:

 

  • Enhanced Submission Quality: By guiding applicants through the submission process, eSTAR helps ensure that submissions are complete and of high quality.

  • Efficient Reviews: The standardized format allows the FDA to conduct premarket reviews more efficiently, potentially speeding up the approval process.

  • User-Friendly: With a user-friendly interface and automated features, eSTAR simplifies the submission process for applicants.

  • Eliminates FDA’s Refusal to Accept Process: The editable pdfs are designed to ensure completeness of FDA submissions and eliminates the Refusal to Acceptable process for hardcopy submissions that are incomplete. 

 

At Landrich Group, we specialize in providing customized Clinical, Quality, and Regulatory consulting services to Medical Device, IVD, and Pharmaceutical companies. Our commitment extends to staying updated with the latest regulations and best practices, allowing us to assist our clients effectively in navigating the submission process. We are here to assist the eSTAR submission process and any other support needed with conducting clinical studies and bringing you products to market with our experienced team. 

 

If you would like to learn more about our Clinical, Quality, and Regulatory consulting services, please visit our website at, www.landrichgroup.com or please feel free to contact us at admin@landrichgroup.com for a complimentary consultation.

bottom of page