FDA issues draft guidance on covering uncertainty in benefit-risk determinations

The FDA this week released draft guidance covering uncertainty in making benefit-risk determinations for certain medical devices, laying out the factors that the agency considers for such determinations.

At the top of the agency’s list are considering “the extent of the probably benefits of the device, including type, magnitude, probability, duration and frequency of those benefits,” according to the draft guidance. The same consideration is applied to risks, including severity, type, number, rates, probability and duration.

The FDA said it also considers the extent of uncertainty regarding the benefit-risk profile of alternative treatments or diagnostics, patient perspective on appropriate uncertainty of the benefit-risk ratio and the extent of the public health need that the device may meet.

Under consideration by the federal watchdog is the feasibility of generating extensive clinical evidence premarket based on appropriate considerations, which takes into account the rarity or prevalence of a disease or condition.

The agency said it considers the ability to reduce or resolve remaining uncertainty of a device’s benefit-risk profile after approval through post-market data collection, and the likely effectiveness of postmarked mitigations to help provide “a reasonable assurance of safety and effectiveness of the device.”

The type of decision being made, including whether its a pre-market approval, humanitarian device exemption, or other submittal, and the probable benefits of earlier patient access to the device are also considered, the FDA said.

“FDA’s consideration of these factors is intended to be pragmatic, context-dependent (considered in the context of the relevant non-clinical and/or clinical information about the device, e.g., information about the device’s mechanism of action and modes of failure), and consistent with FDA’s statutory and regulatory authorities and requirements,” the FDA wrote in its draft guidance.

For de novo requests, the FDA said it “expects the risks associated with the device would pay a large role in its analysis of uncertainty,” and said it may accept greater uncertainty as to probably benefits either due to the nature of the device, or with imposition of special controls.

Earlier this week, the FDA said that new labeling regulations submitted to the FDA’s Office of Management and Budget are expected to add an additional approximate 1.6 million hours of work to record keepers at the agency and in the industry.

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