FDA Issues Draft Guidance on Benefit-Risk Determinations for Premarket Decisions

The FDA released draft guidance outlining the approach it takes when considering uncertainties in benefit-risk determinations to support its premarket decisions.

The draft describes factors the FDA considers when it assesses uncertainties during premarket submission reviews and applies to device PMAs, De Novo requests and Humanitarian Device Exemption applications.

The agency provides examples of how principles for considering uncertainty can apply to clinical evidence and when more uncertainty can be appropriate for PMAs.