We guide sponsors through every stage of FDA device interactions—so you walk in prepared, stay on message, and leave with clarity.
Before the Meeting: Strategy & Preparation
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Define objectives and align meeting type (Q-sub, IDE, PMA, De Novo, 513(g), Breakthrough, or post-market).
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Develop a regulatory and scientific strategy that frames questions to elicit actionable feedback from the FDA.
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Develop briefing packages, slide decks, and supporting documentation.
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Prepare device demonstrations, predicate comparisons, and statistical justifications.
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Conduct mock meetings and spokesperson coaching for tough FDA questions.
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During the Meeting: Facilitation & Advocacy
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Provide experienced facilitators and former FDA reviewers to guide the discussion.
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Keep conversation focused on your priorities and prevent scope drift.
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Deliver real-time note-taking and clarification of FDA feedback.
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Manage tone and dynamics with FDA to avoid confrontations and maintain credibility.
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After the Meeting: Follow-Up & Integration
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Draft accurate meeting minutes that reflect agreements and FDA’s expectations.
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Map commitments into your development plan and regulatory strategy.
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Manage follow-up correspondence, clarifications, or supplemental submissions.
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Ensure feedback translates into actionable requirements for your device program.
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