This week FDA issued a draft guidance to further clarify the considerations related to uncertainty in benefit-risk determinations that support premarket decisions for medical devices. The draft, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions“, intends to make the considerations more “transparent, consistent and objectively-defined,” according to an FDA release.

The draft explains the agency’s consideration of uncertainty “when determining benefit-risk for certain premarket decisions on medical devices based on the totality of the valid scientific evidence,” FDA states. It encompasses devices subject to PMA applications, De Novo requests and humanitarian device exemption applications. The agency notes instances in which there may be greater uncertainty, including breakthrough devices that are subject to PMA and devices intended for small patient populations such as pediatrics—and in these cases, the FDA is more likely to accept this greater uncertainty.

The FDA continues to stand by its flexible and patient-centric approach to assessing a device’s benefit-risk profile.