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A 30-minute discovery call with Andre Butler gives you a clear-eyed assessment of your device's regulatory situation — no generalist advice, no templates. Andre has guided medical device companies through more than 100 FDA submissions across Class I, II, and III device categories, including high-stakes 510(k)s, De Novo classifications, and AI/ML SaMD pathways.

Whether you are preparing a first submission, responding to FDA 483 observations, or trying to determine the right regulatory pathway for a novel device, the discovery call is the fastest way to get your specific questions answered by an FDA regulatory consultant with real practitioner experience.

The call is free and there is no obligation. Most clients leave with a written summary of their regulatory situation and a clear set of recommended next steps.

• Regulatory pathway assessment (510(k), De Novo, PMA, or IDE)
• Device classification and submission type guidance
• FDA 483 and Warning Letter response strategy
• AI/ML SaMD regulatory strategy and PCCP planning
• ISO 13485 QMS gap assessment and readiness review