FDA Issues 510(k)/Substantial Equivalence Draft Guidance Describes Benefit-Risk Factors Considered for New 510(k) Devices with Different Technical Characteristics


On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance document titled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)]with Different Technological Characteristics (“Draft Guidance”). The Draft Guidance focuses on the benefit-risk factors FDA uses to determine whether a new 510(k) device with different technological characteristics that do not raise different questions of safety and effectiveness is as safe and effective as a predicate device. The Draft Guidance does not address factors for determining whether the new and predicate devices have the same intended use or whether the different technological characteristics raise different questions of safety and effectiveness. Comments on the Draft Guidance are due by October 14, 2014 and should reference docket number FDA–2014–D–0900.

Weighing the Risks and Benefits

Broadly, the Draft Guidance notes that FDA considers each risk or benefit factor in comparison to the predicate device. Additionally, FDA reviews each relevant factor both individually and in the aggregate. A finding of decreased benefit or increased risk, as compared to the predicate device, will not necessarily result in a not substantially equivalent (“NSE”) determination. Rather, FDA will balance the benefits and risks and may still reach a substantial equivalence (“SE”) determination.

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