This episode of the Global Medical Device Podcast delves into the world of FDA submissions, specifically focusing on the eSTAR program. Host Etienne Nichols leads an insightful discussion exploring the intricacies, benefits, and strategies for using eSTAR effectively in medical device regulatory submissions.

To discuss this topic, we brought in the following experts:

• Patrick Axtell, Ph.D., the Senior Tools & Templates Engineer for the Office of Regulatory Products at CDRH
• Lisa Pritchard, Vice President of Regulatory, Quality, Clinical and Engineering at DuVal & Associates
• Kathy Herzog, Senior Regulatory, Quality & Compliance Consultant at DuVal & Associates

As of now, all 510K submissions must use the eSTAR program. eSTAR is designed to streamline the FDA submission process, making it more efficient and standardized. This episode is a must-listen for anyone in the medical device industry looking to navigate the complexities of FDA submissions with a focus on the evolving eSTAR program.

Expert Insights:

• Patrick Axtell: Discusses the development of the eSTAR program, its purpose, and benefits, including standardization and automation in the submission process.
• Lisa Pritchard: Shares her 30-year experience in regulatory space and her initial skepticism about eSTAR, which later transformed into advocacy for the program.
• Kathy Herzog: Provides practical advice on using eSTAR, emphasizing the importance of understanding and navigating the program effectively.

Key Strategies:

• Use the help features within eSTAR as a quality control check.
• Start at the beginning of the template to avoid missing critical sections.
• Prepare your submission content outside eSTAR before populating the template.
• Consider the executive summary as a mandatory, not optional, part of your submission for effective advocacy.

Future of eSTAR:

• eSTAR is evolving to include more types of submissions (e.g., PMAs, presubs) and may soon incorporate AI and other technological advances for enhanced efficiency.

Quotes:

1. "Standardized submission means that the reviewer can quickly find information...a huge benefit for both applicants and reviewers." - Patrick Axtell
2. "Even after 30 years, I always open those help boxes in eSTAR...each submission is unique." - Lisa Pritchard
3. "The key with eSTAR is eSTAR(t). You just have to get started...no substitute for just getting familiar with the template." - Kathy Herzog

Reference Links:

• Lisa Pritchard
• Kathy Herzog
• Etienne Nichols
• Greenlight Guru
• DuVal & Associates
• Client Alert: "eSTAR & I"
• FDA eSTAR Program webpage
• FDA electronic Submission Template guidance for 510(k) Submissions
• FDA electronic Submission Template guidance for De Novo Submissions
• YouTube video of FDA REdI Conference presentation on eSTAR by Lili Duan

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