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[FDA News] Starting October 1, 2023, all 510(k) submissions must be submitted through eSTAR



On June 9, 2023, the FDA announced that through eSTAR (The electronic Submission Template and Resource), it is now possible to submit Pre-Submissions to the Center for Devices and Radiological Health (CDRH). This is a voluntary procedure, but starting from October 1, 2023, all 510(k) submissions for medical devices, excluding exempted devices, must be submitted online through eSTAR.



What is Estar?


eSTAR (The electronic Submission Template and Resource) is a PDF template designed in an interactive format for the pre-market notification process of medical devices, specifically for the submission of 510(k) and De Novo documents. eSTAR consists of questions, text, and guidance within the PDF template to assist users in completing and submitting their 510(k) electronic submissions.


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 benefits of eSTAR


The eSTAR program was created to facilitate processing specific types of regulatory submissions online. This interactive system uses standardized templates and is designed to provide the necessary submission documents based on the responses. During the question-and-answer process, the template automatically adds or removes sections. As a result, submitters can easily understand the submission requirements set by the FDA and ensure that all the necessary documents are included in their submissions. Additionally, the FDA can review the comprehensive data provided by the submitters to efficiently ensure the safety and quality of medical devices before they are marketed, thus promoting these processes effectively.



To prepare for eSTAR submissions, here are some tips:


Plan Ahead: Set aside dedicated time to plan and prepare for the submission. Understand the requirements and timelines involved to ensure a smooth process.


Create an Internal Checklist: Develop a checklist that outlines the items that are already prepared and the ones that still need to be collected. This will help you keep track of what is complete and what is pending.


Use the Template to Identify Missing Items: Since the template is structured based on responses, it can serve as a guide to check if any required items have been missed. Before inputting all the information into the template, take the time to collect any missing documents using this approach.



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