FDA eSTAR Program - Overview, Timeline and Key Insights

Introduction to eSTAR FDA Program:

The eSTAR (Electronic Submission Template and Resource) program is a program by the FDA to streamline the submission process for medical devices. It aims to enhance the submission process for medical devices.

Challenges: Challenges persist in the eSTAR FDA program, impacting the 510(k) submission process for medical devices.

Examples of Challenges:

1. Submission Delays: Current regulations and procedures in flux lead to delays in the submission process.
2. Organizational Flux: Businesses constantly adapt to evolving regulations, causing challenges in aligning with eSTAR requirements.
3. Early Experiences: The voluntary nature of eSTAR templates led to variations in experiences, highlighting initial challenges.
4. Complex Templates: While eSTAR organizes information for FDA review, complexities arise in adapting to its internal templates.

Timeline:

Until October 1, 2023, eSTAR was a voluntary and free process for medical device applicants submitting 510(k) or De Novo applications to the CDRH. eSTAR became mandatory starting October 1, 2023 and the FDA announced on October 3, 2022, that electronic Submission Template And Resource (eSTAR) could be used for 510(k) submissions. Standard submission fees apply for De Novo and 510(k) . Notably, eSTAR submissions do not require Refuse to Accept (RTA) reviews; instead, the eSTAR template serves as a checklist for completeness.

References:

1. FDA - eSTAR Program
2. Essenvia - Your Guide to the FDA eSTAR program
3. The FDA Law Blog - The Good, Bad, and Ugly side of 510(k)s—HP&M's Early Experience
4. Medical Device Academy - eSTAR draft guidance is here, and wicked eSubmitter is...

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