How to prepare and submit an eStar 510k Submission as of October 1st

How to prepare and submit an eStar 510k Submission as of October 1st

Navigating FDA Registration and the 510(k) Process: Your Guide to Getting Your Medical Device to Market

Introduction: 

Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023, the FDA introduced the electronic Submission Template and Resource (eSTAR) for Pre-Submissions, revolutionizing the process for medical device applicants. Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using the eSTAR template. Given this impact on the medical device industry, we’ll answer all your questions about eSTAR in this blog. This article is simply a high-level analysis of the guidance document simplified to give you the most important information broken down but is not a substitute for the full FDA guidance document. 

What Is the eSTAR Template? 

The eSTAR template is your go-to tool for preparing electronic submissions of medical devices, simplifying the process significantly. It’s an interactive PDF form designed to guide applicants through creating a comprehensive submission. With automation features, alignment with FDA review templates, integration of resources, guided section construction, and automatic verification, the eSTAR template streamlines the submission process.

Why Choose eSTAR? 

Aside from it being a requirement eSTAR is available for voluntary use by all medical device applicants, whether you’re submitting 510(k)s, De Novo requests, or Pre-Submissions to the Center for Devices and Radiological Health (CDRH). It’s also applicable for those offering 510(k)s to the Center for Biologics Evaluation and Research (CBER) and combination products.

What Are the Benefits? 

The eSTAR template aims to enhance submission quality by facilitating comprehensive data submission in a standardized format. This ensures completeness, helping the FDA conduct premarket reviews more efficiently. The best part? It reduces the likelihood of your submission undergoing a refuse-to-accept (RTA) process.

How to Get Started with eSTAR:

  • Download the eSTAR PDF template following simple steps.
  • Familiarize yourself with the template’s instructions.
  • Use the template to construct your submission.

Important Tips:

  • Be cautious of file sizes to ensure smooth submission.
  • Combine similar attachments for better organization.
  • You don’t need to include additional forms if you’re using eSTAR.

eSTAR Application Review Process:

  • The FDA conducts a virus scanning and technical screening process for eSTAR submissions.
  • Incomplete eSTAR submissions will be held until completed.
  • Subsequent review processes follow FDA guidelines for substantial equivalence and De Novo classification requests.

How to Submit your eSTAR 510k application: 

Choose from various submission methods, including online through the Electronic Submission Gateway, the CDRH portal, or by mail. Stay updated and make your medical device submissions more efficient with the eSTAR template – your gateway to smoother FDA interactions.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification

Frequently Asked Questions about eSTAR

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About the author

Andrew Parshad
Andrew Parshad
Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices.

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