Efficient Premarket Applications: Three FDA Submission Paths That Require Less Time, Money and Effort

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Efficient Premarket Applications
Three FDA Submission Paths That Require Less Time, Money and Effort

What is your premarket application strategy?

Devicemakers can pass over the most common pathways in favor of three lesser-used programs that require less time, money and effort:

  • The De Novo program
  • Early Feasibility/First-in-Human Studies
  • The Expedited Access Pathway

All three of these options bypass the lengthy clinical trial and literature search processes and offer opportunities for rapid FDA feedback that can strengthen your application’s chance of success.

This report explains the criteria for each pathway, how to determine which one is right for your device and strategies for success. Fictional cases illustrate how the different pathways can be used. You will learn:

  • The benefits and requirements of the de novo, early feasibility/first-in-human and expedited access pathways

  • How to determine which pathway is the most efficient for you

  • How the passage of the 21st Century Cures Act and the impending MDUFA goals are potential game-changers in pathway determination

  • How to optimize effective communications with the FDA, depending on which pathway is best suited for your product

Order your copy of Efficient Premarket Applications and save time and money in the submission process.

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Who Will Benefit

  • Regulatory Affairs
  • Quality Assurance
  • Clinical and Medical Affairs

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