Navigating Pediatric Regulatory Pathways

April 16th, 12:00pm – 1:00pm ET.

This session is designed to provide critical insights into the complex world of FDA regulations for medical devices intended for pediatric use.

During this webinar, our expert panel will delve into key topics, including:

• Understanding the Latest FDA Changes and Requirements: We’ll explore the most recent updates and guidelines specifically tailored for pediatric medical devices. This will include discussions on evolving standards and best practices for ensuring compliance.

• Device Type and Its Impact on FDA Interactions: We’ll examine how the specific type of medical device you’re developing influences your interactions with the FDA. Special attention will be paid to the unique regulatory considerations for Software as a Medical Device (SaMD) in the pediatric space.

• Developing Tailored Regulatory Strategies: Our panelists will provide practical advice on creating effective regulatory strategies that address the unique needs of pediatric populations. This will cover topics such as clinical trial design, data collection, and post-market surveillance.

• Practical Guidance and Q&A: We’ll provide real-world examples and offer a dedicated Q&A session, allowing you to address your specific questions and concerns directly with our experts.

Why Attend?

• Gain a comprehensive understanding of the current regulatory landscape for pediatric medical devices.

• Learn how to effectively navigate FDA requirements and streamline your regulatory pathway.

• Discover best practices for developing tailored regulatory strategies for your specific device type.

• Connect with experts and peers in the pediatric medical device field.