Taking the High Road to FDA Approval

Jeff’s Talk at Colorado Bioscience Association

According to the FDA, there are common reasons for Medical Device Use Errors

  • The use environment has negative effects
  • The demands associated with the use of the device exceed the user’s capabilities
  • Aspects of device use are inconsistent with the user’s expectations or intuition
  • The device is used in unexpected ways
  • The device is used in inappropriate but foreseeable ways, for which adequate controls were not applied

The Guiding Document reorients FDA submissions by focusing on the USER REQUIREMENTS, not the device requirements.
Jeff had a dialogue with Colorado scientists who are developing medical devices to find the High Road to FDA approval. We’ve uploaded the slides here as a resource.