The FDA considers factors such as:

• The extent of the probable benefits of the device, taking into account the type, magnitude, probability, duration, frequency of those benefits, including if the probable benefits are greater than those of approved or cleared alternative treatments or diagnostics or the standard of care
• The extent of the probable risks of the device, taking into account the type, magnitude, probability, duration, frequency of those benefits, including if the probable benefits are greater than those of approved or cleared alternative treatments or diagnostics or the standard of care
• The extent of uncertainty regarding the benefit-risk profile of approved or cleared alternative treatments or diagnostics or the standard of care
• The patient’s perspective on appropriate uncertainty about the probable benefits and risks of the device, if available
• The extent of the public health need (e.g. seriousness of the illness; benefit-risk profile of other available therapeutics or diagnostics, if any, including the current standard of care; the portion of the target population for whom there would be a positive benefit-risk profile)
• The feasibility of generating extensive clinical evidence premarket based on appropriate considerations, e.g. considering the prevalence of the disease or condition
• The ability to reduce or resolve remaining uncertainty of a device’s benefit-risk profile postmarket (e.g. consideration of FDA’s authority to require postmarket data collection and the likelihood that the necessary postmarket data collection will be completed within reasonable time frames)
• The likely effectiveness of mitigations, such as labeling, and other tools to help provide a reasonable assurance of safety and effectiveness of the device, as applicable
• The type of decision being made (e.g. there is generally likely to be more uncertainty surrounding a device’s benefit-risk profile based on the evidence submitted in an HDE application, as compared to a PMA, because the standards for approval are different
• The probable benefits of earlier patient access to the device

FDA’s consideration of these factors is intended to be pragmatic, context-dependent, and consistent with FDA’s statutory and regulatory authorities and requirements.

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