Substantial Equivalence Factors Explored In FDA Draft Guidance on 510(k) Reviews

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By Michael D. Williamson  

July 17 — The FDA has released a document to increase awareness of the factors it considers when making premarket notification submission decisions for new devices.

The July 15 Food and Drug Administration draft guidance said that the agency issued the document “to improve the predictability, consistency, and transparency of the” device premarket notification process, also known as 510(k). Comments on the draft guidance are due Oct. 14, according to a July 15 Federal Register notice announcing the document (Docket No. FDA-2014-D-0900).

Specifically, the draft guidance offers information on the factors considered in a 510(k) when determining substantial equivalence (SE) to a legally marketed device, or predicate device, with different technological characteristics. The guidance said, “in order to find a new device SE to a predicate device, FDA must first find that the two devices have the ‘same intended use.' FDA must then determine that the two devices have ‘the same technological characteristics,' or that any differences in technological characteristics do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.”

According to the document, “the benefit-risk factors discussed in this guidance may assist FDA reviewers in making” SE decisions “and may help accommodate evolving technology during the 510(k) premarket process.” In addition, the agency said that the guidance may help 510(k) premarket notification submitters show SE.

The title of the document is “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics.”

Benefits, Risks

The guidance outlined the benefit, risk and other factors that the FDA uses to determine that a new device is equivalent to a predicate device with different technological characteristics in a 510(k).

To assess the benefits of a device during a 510(k), the guidance described a process to measure the extent of the probable benefits. The guidance identified factors that the FDA will use to gauge the extent of probable benefits, including the type of benefit, magnitude of the benefit, probability of the patient experiencing one or more benefits and duration of effects. In addition, the guidance specified several components for each factor.

Similarly, to assess the risks of devices during a 510(k), the guidance said, the FDA considers the extent of the probable risks or harms. According to the guidance, the severity, types, number and rates of harmful events associated with the use of the device, probability of a harmful event, probability of the patient experiencing one or more harmful events, duration of harmful events and risk from false-positive or false-negative results for diagnostics represent the factors used to measure the extent of probable risks or harms. Several components of each factor are included in the guidance.

The guidance also identifies several additional factors in the assessment of the benefits and risks of devices for a 510(k). The additional factors are uncertainty, characterization of the disease/condition, patient tolerance for risk and perspective on benefit, benefit for the health-care professional or caregiver, risk mitigation, postmarket data and innovative technology.

Benefit-Risk Evaluation Examples

Seven examples of benefit-risk evaluations are also included in the guidance. The examples represent either hypothetical or simplified real-world situations of companies seeking to show that their new product is substantially equivalent to a predicate device with different technological characteristics, the guidance said.

When it's final, the guidance will represent the FDA's current thinking on benefit-risk factors to consider when determining SE during a 510(k), the document said. Furthermore, the document said that the guidance is intended as recommendation on the topic and doesn't establish legally enforceable responsibilities.

To contact the reporter on this story: Michael Williamson in Washington at

To contact the editor responsible for this story: Brian Broderick at

The FDA draft guidance is at

The July 15 Federal Register notice is at

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