FDA Spells Out Use of Risk-Benefit Factors in Device Approvals

August 31, 2016

The FDA has issued guidance describing in detail how the risks and benefits of a new device should be considered when the device is up for premarket approval or de novo classification.

In its decisionmaking, the FDA will consider the types of benefits, their magnitude, the probability of the patient having one or more benefit and the duration of effects.

It will also consider the extent of the probable risks and harms, including severity, types, device-related adverse events, procedure-related complications, and the number and rates of harmful events associated with the device.

When assessing the probability of a harmful event, the FDA will consider the portion of the intended patient population likely to experience the event, factoring in whether the event occurs once or repeatedly. It will also consider duration and severity, as some adverse events may be reversible while others can cause permanent harm. — April Hollis

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