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.
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, Regulatory Compliance Associates
Jordan has 15+ years of global regulatory comprehensive background in medical device regulations and a demonstrated history of successful product submissions including; FDA 510(k), EU Class IIa and IIb, Health Canada Class III, COFEPRIS Class III, and CFDA Class III submissions.
Anita Michael – Executive Principal Consultant, Pharma Compliance, Regulatory Compliance Associates
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.
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].