Mastering the FDA’s eSTAR Submission Process
Blair Anderson
Founder & Recruiter | Medical Device Senior Appointments | Regulatory Affairs | Executive & Commercial Specialist | Passionate Golfer & Devoted Dog Lover
The FDA's eSTAR (electronic Submission Template and Resource) program took effect on October 1, 2023, representing a significant shift in handling medical device submissions. Imagine moving from an old-school filing cabinet to a sleek digital dashboard. This transition isn’t just about going paperless; it’s about streamlining, standardizing, and simplifying the submission process.
Current State
Previously, medical device submissions to the FDA involved each manufacturer’s electronic and physical media mix. This included the eCopy program, where applicants submitted documents on CDs, DVDs, or USB drives. These submissions had to follow strict formatting and file size guidelines, which often led to delays due to technical issues. Applicants could also submit documents via the CDRH Customer Collaboration Portal, which allowed for online tracking but faced limitations in file sizes and formats.
The Need for Change
The push towards eSTAR was driven by the need to modernize, standardize and streamline these processes. With the explosion of medical device innovation and the complexities introduced by new technologies, the traditional methods became increasingly unsustainable. The COVID-19 pandemic further highlighted these inefficiencies, as regulatory bodies worldwide faced unprecedented pressures to expedite reviews while managing vast amounts of data. The risks to manufacturers and the FDA included:
The FDA introduced the eSTAR program to address these challenges by providing a standardized, electronic submission format. This transition aims to improve the quality and consistency of submissions, reduce administrative burdens, and ultimately accelerate the review process, ensuring that safe and effective medical devices reach patients more quickly.
Using eSTAR Effectively
1. Use the Correct Template and Version. Think of eSTAR templates as your recipe book. Just as you wouldn’t use a cookie recipe to bake a cake, you need to choose the right eSTAR template for your submission:
Non-In Vitro Diagnostic eSTAR: For 510(k), De Novo, and PMA submissions.
In Vitro Diagnostic eSTAR: This is for similar submissions but is specific to in-vitro diagnostics.
Early Submission Requests (PreSTAR): For pre-submissions and specific requests for information under 513(g).
Always download the latest version of the template from the FDA's website to stay current with any updates or changes. They’re updated regularly, so keep an eye on it.
Helpful Link: FDA eSTAR Templates
2. Summarize Carefully to Avoid Disclosing Confidential Information. Do not enter confidential or proprietary information in the summary sections of the eSTAR forms. Think of these sections as the back cover of a cookbook—they give an overview without revealing the secret sauce. These sections could potentially be accessed through FDA Freedom of Information Act (FOIA) requests, so keep detailed or sensitive information within the attachments instead.
Helpful Link: FDA FOIA
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3. Combine Similar Attachments To streamline your submission (and make it easier for reviewers to navigate), combine documents of similar content into a single PDF. You can use bookmarks or a table of contents within these PDFs to help you navigate. This simplifies the review process and ensures you stay within size limits for attachments. Think of it like organizing chapters in a book; it’s much easier to follow when related content is grouped.
4. Store Attachments in an Easily Editable Format When a submission is in process with the FDA, think of time operating like a chess clock: when you make your submission, the FDAs clock starts ticking, and as soon as they ask questions about your submission, their clock stops, and your clock begins ticking. ?So, before converting documents into PDFs and attaching them to your eSTAR submission, store them in a secure but retrievable location in an easily editable format. This makes it easier to update and replace documents if needed. ?Remember, once a document is attached, it can only be edited by replacing the entire PDF submitted to the FDA.
5. Register for the Center for Devices and Radiological Health (CDRH) Portal. Submit your eSTAR through the CDRH Portal for the Center for Devices and Radiological Health. This portal not only allows for submission but also provides a progress tracker for your submissions. Pay any required FDA user fees before submission and register for Small Business certification if applicable.
Helpful Link: CDRH Portal Registration
6. Notable dates
October 1, 2023: Starting from this date, all 510(k) submissions must be made using the eSTAR format.
September 30, 2025: Finalization of the guidance for mandatory electronic submissions for all De Novo classification requests. This date marks the deadline for the FDA to incorporate public feedback and finalize the guidance for De Novo submissions.
Additional Resources:
Original PMAs
PMA Panel Track Supplements (PTS)
PMA Real-Time (RT) Supplements
PMA 180 Day Supplements
By following these tips, you can ensure your eSTAR submissions are complete, accurate, and efficiently processed by the FDA. This speeds up the review process and helps get your medical devices to market more quickly.
Article Sources FDA eSTAR Program, MedEnvoy on FDA eSTAR, MedHealthReview on eSTAR, FDA 510(k) Submission Process, FDA eCopy Program, FDA Premarket Submissions
Very helpful!