Unlocking Regulatory Complexities for Combination Products

Regulatory combination productsThe Key to Combination Product Success

The shifting borders among traditional drugs, biologics and medical devices are poised to produce safer and more effective combination products that offer new diagnostic and treatment options for patients. But such novel combination products pose numerous regulatory hurdles for sponsors, even when comprised of previously cleared components — devices, delivery systems, compounds or biologics.

This paper explores medical device combination product strategies to improve the regulatory journey from classification to market clearance for sponsors.

 

Learning Objectives

  • Understand five key aspects to combination product regulatory strategy
  • Learn how to determine a product’s identify and choose the best regulatory pathway
  • Review our staged, three-step approach to clinical trials

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