FDA Clarifies Policies on Acceptable Levels of Uncertainty for Devices
The US Food and Drug Administration (FDA) issued draft guidance Wednesday to update the current framework on acceptable levels of uncertainty in regulatory decision-making for medical devices.The draft guidance is intended to further clarify the approach used by agency staff when making benefit-risk determinations for certain device submissions.
The draft elaborates on policies set forth in 2016 final guidance on premarket approval applications (PMAs) and de novo requests. This involves describing the critical factors FDA staff considers in making determinations on applications for humanitarian device exemptions or breakthrough devices intended for smaller patient populations.
The move underscores a shift toward greater use of postmarket data in response to recent legislative actions, including the expansion of the FD&C Act’s least burdensome provisions.
The draft guidance acknowledges the need for “considering the applicable patient population’s willingness to accept more uncertainty in a device’s benefits and risks, particularly when there are no acceptable alternatives available” in order to “appropriately address uncertainty in benefit-risk determinations supporting certain FDA premarket decisions.”
FDA