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Free eBook:

Streamlining the Regulatory Path to Market for Low-Risk Medical Devices

US-based companies dominate the roughly $350 billion global medical device industry, and, as a result, America exports more medical devices than it imports.

Although the process of FDA clearance for Class I and II medical devices is simpler than for medical drugs and Class III devices, the various submission standards are not always obvious or intuitive, and failure to properly navigate them can lead to wasted resources at best and federal prosecution at worst.

In this eBook, we review vital steps in receiving FDA clearance of Class I and II medical devices and strategies for streamlining the process.

Download this eBook to learn more about:

  • Understanding the classes and corresponding regulatory controls
  • Confirming your device’s classification
  • Identifying predicate devices already cleared for sale
  • Defining your device’s Intended Use
  • Developing a regulatory and strategic pathway

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