Interacting with FDA and Regulatory Bodies

Planning an FDA medical device submission?

Former FDA Team Leader and current PAVmed Inc. Vice President, Regulatory and Quality, Deepika Lakhani, and StarFish Medical Vice President of QA/RA, Nicole Ouellet share strategies and lessons from their years of delivering and evaluating medical device submissions to FDA and other Regulatory bodies.

Topics include:

• Lessons learned from a former FDA reviewer
• Regulatory pathways that enable innovation
• De novo case study
• Regulator pre- meeting briefing document tips
• Key stakeholders for a pre-submission meeting
• Positioning pre-submission meeting questions

Scott Phillips, Medical Device Playbook and StarFish Medical Founder, hosts and moderates live audience Q&A with presenters.

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