An overview of FDA’s premarket regulation of medical devices

Whether you're new to the medical device regulatory space or looking to sharpen your knowledge on the subject, listen as Laurie Clarke, Head of TSG Consulting’s medical device regulatory practice, discusses the fundamentals of FDA’s regulatory framework for marketing a device.

Duration: 66 minutes

Topics covered: 

  • FDA’s legal and regulatory framework
  • The definition of a medical device
  • FDA’s risk-based classification of a device
  • Paths to market for medical devices
  • 3 primary types of premarket submissions
  • 510(k) premarket notifications
  • De Novo requests regarding automatic Class III classification
  • Premarket approval applications
  • FDA’s regulation of clinical studies
  • Case study:  The first FDA-cleared hair growth device
  • Regulatory tips

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