FDA release draft guidance on the uncertainty of medical device benefit-risk determinations

The US Food and Drug Administration (FDA) have released draft guidance regarding acceptable levels of uncertainty when it comes to the risk-benefit balance of medical devices.

The guidance is targeted for both industry and agency staff and hopes to clarify the FDA’s approach and policies as well as improve the consistency of the premarket review process when making benefit-risk determinations for:

  • Medical device premarket approval applications (PMAs)
  • De Novo requests
  • Humanitarian device exemption (HDE) applications.

A link to the guidance can be found here.