This presentation provides a comprehensive overview of the FDA’s medical device pre-submission 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 pre-submission program (Q-Sub), outlining key components and benefits.
Webinar
Navigating the FDA’s Medical Device Pre-submission Process
Key takeaways will include:
- When to begin interfacing with FDA: Identify when your company should initiate the pre-submission process to maximize efficiency and reduce testing mistakes.
- Maximizing your pre-submission 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 pre-submission 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 pre-submission process to their advantage, ultimately accelerating their product’s journey to market.
Presenters
Jordan Elder
Director, Regulatory Affairs
Jordan Elder has almost 15 years of experience navigating regulatory pathways and identifying optimal regulatory strategies for both pharmaceutical and medical device companies. As Regulatory Compliance Associates® (RCA) Director of Regulatory Affairs, he is responsible for providing our clients with... Read More
Anita Michael
Executive Principal Consultant, Pharma Compliance
Anita has 24+ years of global regulatory and quality experience, including 16 years’ operating globally as a Pharmaceutical Expert, FDA Investigator and FDA Pre-Approval Manager. She specializes in preparation, remediation and designing of training for individuals at all levels of an organization.
Thor Rollins
Biocompatibility Expert, Nelson Labs
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He is a participating member of multiple committees and plays an active role along with the FDA in developing standards, discussing biocompatibility methods, and voting on changes.