Join Regulatory Compliance Associates (RCA) at the annual Utah Life Science Summit in Salt Lake City November 14th. Anita Michaels, RCA’s Executive Pharma Compliance Expert & Principal Consultant, and Jordan Elder, RCA’s Director of Regulatory Affairs, will be presenting with Thor Rollins, VP, Global Segment Leader of Medical Devices at Nelson Labs, on Navigating the FDA’s Medical Device Presubmission Process.

This presentation provides a comprehensive overview of the FDA’s medical device presubmission process, a critical step for manufacturers seeking to efficiently bring safe and effective devices to market. This session will examine the strategic advantages of utilizing the presubmission program (Q-Sub), outlining key components and benefits.

Key takeaways will include:

• When to begin interfacing with FDA: Identify when your company should initiate the presubmission process to maximize efficiency and reduce testing mistakes.
• Maximizing your presubmission interaction: Discover how to effectively prepare your submission and engage with the FDA to obtain valuable feedback on your device’s regulatory pathway, clinical trial design, and data requirements.
• Common pitfalls and best practices: Gain insights into common mistakes to avoid and strategies to optimize your presubmission experience for a smoother and faster FDA review process.
• Real-world examples: Discuss how manufacturers have recently maximized their interactions with FDA or, in some cases, caused additional work to be required.   

This presentation is essential for medical device manufacturers, regulatory professionals, researchers, and anyone involved in developing and commercializing medical devices in the United States. Attendees will better understand how to leverage the presubmission process to their advantage, ultimately accelerating their product’s journey to market.