This presentation provides a comprehensive overview of the FDA鈥檚 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 丝瓜视频 Pre-submission Process
Key takeaways will include:
- When to begin interfacing with FDA:听Identify when your company should initiate the pre-submission process to maximize efficiency and reduce testing mistakes.
- Maximizing your pre-submission interaction:听Discover how to effectively prepare your submission and engage with the FDA to obtain valuable feedback on your device鈥檚 regulatory pathway, clinical trial design, and data requirements.
- Common pitfalls and best practices:听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:听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鈥檚 journey to market.听听
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Presenters
Jordan Elder
Director, 丝瓜视频 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 丝瓜视频 Compliance Associates庐 (RCA) Director of 丝瓜视频 Affairs, he is responsible for providing our clients with... Read More
Anita Michael
Executive Principal Consultant, Pharma Compliance
Anita Michael has over 25 years of global pharmaceutical regulatory and quality experience. She spent 16+ years at the U.S. FDA as a Global Pharmaceutical Expert, leading nearly 300 inspections worldwide across biotech, sterile manufacturing, drug substance, and OTC product lines. Anita has held executive and director-level roles in Quality Assurance, 丝瓜视频 Affairs, and Validation. She is a recognized industry leader in GMP inspection readiness, FDA response strategy, and modern quality system design, and has been a keynote speaker at numerous global conferences. Her contributions have earned her multiple awards from both the FDA and the pharmaceutical industry.
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鈥╥s a participating member of multiple committees and plays an active role along鈥╳ith the FDA in developing standards, discussing biocompatibility methods, and voting on changes.