Health Futures

is a government relations, public policy and strategic development firm representing clients in the dynamic new world of predictive and personalized health care. We specialize in navigating the labyrinth of legislators, regulators, health care providers, patient advocates, third-party payers, and journalists who will ultimately determine if innovation succeeds or fails.

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Medical device approval and clearance

This is a crucial time for medical device manufacturers. The Food and Drug Administration (FDA) is in the midst of a major overhaul of the medical device approval and clearance pathways. The agency also is developing its regulatory scheme for laboratory tests and mobile health products. CRD Associates represents traditional medical device manufacturers, purveyors of digital and mobile health products and commercial and academic-based hospital laboratories that develop laboratory tests. CRD Associates helps medical device manufacturers anticipate changes to regulatory pathways and modify their business strategies accordingly.

  • CRD Associates has assisted several genetic testing companies with their response to Food and Drug Administration (FDA) enforcement action questioning their regulatory compliance. Part of our work included preparing company executives for congressional hearings on industry practices by drafting testimony, providing briefing materials and holding mock hearings.