eSTAR Medical Device Submissions

The eSTAR (Electronic Submission Template and Resource) is an interactive PDF form designed to assist applicants in preparing comprehensive medical device submissions. It offers various features such as automation, content and structure complementing FDA internal review templates, integration of multiple resources, guided construction for each submission section, and automatic verification.

The eSTAR will begin to replace the e-submitter e-copy format beginning this fall. As of October 1, 2023, all medical device submissions and their supplements will need to be submitted in eSTAR format through the CDRH Portal. However, any submissions that were acknowledged, via FDA Acknowledgement Letter, before October 1, 2023 will be grandfathered, and you will not need to submit supplements to these grandfathered 510(k)s in eSTAR format via the CDRH Portal.

Currently, eSTAR is available for voluntary use by medical device applicants who wish to submit 510(k)s, De Novo requests, and Pre-Submissions to the Center for Devices and Radiological Health (CDRH). It is also applicable for medical device applicants submitting 510(k)s to the Center for Biologics Evaluation and Research (CBER), including combination products.

The purpose of the eSTAR is to enhance the quality of submissions for medical devices, ensuring comprehensive data for premarket review. By using a standardized format, submitters can ensure completeness, and the FDA can conduct reviews more efficiently, promoting timely access to safe and effective medical devices.

The submission process involves downloading the appropriate eSTAR PDF template and following the instructions provided. The completed eSTAR is not directly submitted but can be sent through the CDRH Customer Collaboration Portal (CDRH Portal) online or via mail to the CDRH Document Control Center (DCC). The eSTAR is exempt from the Refuse to Accept (RTA) review process due to automatic verification.

The FDA has also introduced a voluntary eSTAR Pilot Program for CBER premarket notification (510(k)) submissions. Participants gain experience with the review process using the eSTAR template. For CBER-specific inquiries, contact the CBER Manufacturers Assistance and Technical Training Branch (MATTB).

It is important to consult the provided guidelines for specific instructions on preparing and submitting an eSTAR. The FDA emphasizes adherence to file size and count limitations and recommends compressing images and videos in compatible formats. Feedback and questions can be directed to the appropriate FDA eSTAR contacts.

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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