How FDA Makes Benefit-Risk Determinations for Medical Devices

In March 2012, FDA issued a finalized version of its guidance titled, “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”. Although the explicit scope of this guidance is limited, the benefit and risk considerations are broadly applicable to any type of device review.

FDA considers four factors when evaluating the potential benefits of a medical device:

  • The effect the device is supposed to have on patients’ health or health outcomes
  • The magnitude of the effect
  • The probability that at least one patient will have improvements in health/health outcomes attributable to the device
  • The duration of the effect

In assessing risk, FDA considers how likely the device is to cause harm, what kind of harm it may cause, and how frequently harmful events occur. If a device is to be used in the context of a clinical procedure, the potential for adverse impact relative to the procedure must also be considered. For example, a surgical device has the potential to extend anesthesia time, which increases risk. Any increase in risk should be balanced by the anticipated benefit so that the overall risk-benefit ratio remains favorable.

FDA also takes into account the indication for the device, the availability of other treatments and patient perspectives. How a patient feels about the acceptability of potential harm from any given treatment depends heavily on how they perceive their present quality of life, what other options they have (or do not have) and what level of benefit they hope to receive.

Greater risk may be acceptable if balanced by prospective benefit from a new technology that addresses a previously unmet medical need. In some cases, it may be possible to mitigate risk to such a degree that the probability of harm becomes acceptably low.

The full guidance document includes a worksheet that may be helpful to review committees evaluating medical device protocols. FDA has also provided several examples to illustrate how the risk and benefit factors can be applied in realistic scenarios.

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