On September 25, 2018, FDA issued Guidance on benefit-risk factors to consider when determining substantial equivalence (SE) in premarket notifications (510(k)) with different technological characteristics.
The purpose of this Guidance is to provide direction to 510(k) submitters on what FDA considers during a safety and effectiveness analysis. 510(k) submitters must demonstrate a new device has SE to a predicate device in order to gain new device clearance. A submitter establishes SE by first demonstrating to FDA that the new device has the “same intended use” as the predicate device. If FDA subsequently finds the devices have the same technological characteristics, the new device is deemed to have SE with the predicate device. Alternatively, the submitter can demonstrate to FDA that the devices have different technological characteristics, but these differences do not raise dissimilar questions as to the safety and effectiveness of the new device.
A safety and effectiveness analysis compares the benefit-risk profiles of the predicate device to the new device. A benefit-risk assessment should be conducted in two scenarios: (1) the new device increases risk and has equivalent or increased benefit compared to the predicate; or (2) the new device decreases or has equivalent risk and has decreased benefit compared to the predicate. FDA takes numerous factors into consideration to determine the aggregate benefits and aggregate risks of the device and the predicate.
Examples of device benefits include the ability to predict future disease onset and increase in efficiency or examination procedures. The benefit magnitude and the probability of a patient experiencing the benefit are considered. Examples of common device risks are adverse device performance and patient intolerability. FDA considers the severity, number, probability, and duration of harmful events when evaluating device risk.
FDA acknowledges variability among benefits and risks. FDA takes further factors into account to combat these discrepancies: the characterization of the disease, the innovation of the technology, and the risk mitigation caused by the new device and predicate. If the aggregated benefits outweigh the aggregated risks, FDA will likely grant SE. In contrast, FDA will likely not grant SE if the risks outweigh the benefits.
Readers are encouraged to read the Guidance, also available on FDA’s website.
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