When is a detailed benefit-risk analysis required by the FDA to determine if a device is substantially equivalent to a legally marketed predicate device?
To determine whether a new medical device is substantially equivalent, the FDA looks at intended use and technological differences which may impact safety or effectiveness. If there are technological differences, the agency will review the test methods and data used to demonstrate substantial equivalence.
The review of the test methods and data looks at the benefit-risk profile of a new device in comparison to the predicate device. Benefit-risk interpretations can be subjective.
Final Guidance on Benefit-Risk Factors
To provide more clarity to device makers, the agency issued a 25-page final guidance document on September 25, 2018 called, “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics Guidance for Industry and Food and Drug Administration Staff“ for this final benefit-risk profile review.
The document is intended to provide guidance when the benefit-risk profile of a new device is different from that of the predicate device.
According to the document, the benefit-risk profile of a new device does not need to be identical to the predicate device for it to be substantially equivalent to the predicate device. The guidance further describes the types of submissions where FDA would recommend sponsors include a benefit-risk assessment within the 510(k).
For devices where the benefit-risk profile includes an increased or equivalent benefit with a decreased or equivalent risk, “FDA will generally determine the device substantially equivalent” and a benefit-risk assessment in the 510(k) will not be needed. If the new device has increased risk with a decrease in benefit, the guidance states that “FDA will generally determine the device not substantially equivalent to the predicate device” and conducting a detailed risk-benefit analysis would also not be warranted.
For situations where there is an increase in risk with an increase or equivalent benefit or a decrease or equivalent risk with a decrease in benefit, including a benefit-risk assessment within the 510(k) is warranted.
Not Legally Enforceable
As you read the guidance document keep in mind, that guidance documents do not establish legally enforceable responsibilities. Instead, according to the agency, “… guidance documents describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required.”
To read the entire document, click here.
