The United States (US) Food and Drug Administration (FDA) has finalised guidance on evaluating the benefit-risk profile of medical devices submitted under the 510(k) pathway that have the same indication as their predicate devices but have different technological characteristics and benefit-risk profiles.
The FDA hopes the guidance will address situations when a new device carries an increase in risk with an increased or equivalent benefit, or when a new device carries a decreased risk and a decreased or equivalent benefit compared to its predicate device.
The guidance is a final version of the draft that was published in 2014, and now includes a flow chart and table which aims to help determine when a benefit-risk assessment is recommended. The FDA advises the industry to read the guidance in conjunction with FDA’s 2014 510(k) program guidance, which details the FDA’s approach to evaluating substantial equivalence. It is important to note that the new guidance does not add any new regulatory requirements for medical devices, and does not change the FDA’s standards for determining substantial equivalence under the 510(k) pathway.
The FDA states that the benefit-risk profile of a new device does not need to be the same as its predicate to be considered substantially equivalent, however the FDA notes that a benefit-risk assessment should be carried out in certain circumstances when the benefit-risk profile is different between the devices.
The guidance also describes how the FDA assesses the different aspects of benefits and risks of devices. With regards to benefits, the FDA explains how they assess the magnitude of benefits, the probability of a patient experiencing one or more benefit(s), and the duration of the effect(s). For risks, the FDA considers the severity, types, number and rates of harmful events, the probability of those events, the duration of harmful effects and the risk posed by a false-positive or false-negative result from a diagnostic.
To read the FDA guidance on benefit-risk factors to consider when determining substantial equivalence in premarket notifications (510(k)) with different technological characteristics, please click here.