The US Food and Drug Administration (FDA) on Monday finalized 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.
FDA says the guidance is meant to address situations when a new device carries an increase in risk accompanied by 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 25-page guidance finalizes a draft version
from 2014 and includes a flow chart and table meant to help determine when a benefit-risk assessment is recommended. The guidance is meant to be read in conjunction with FDA’s 2014 510(k) program guidance
, which details the agency’s approach to evaluating substantial equivalence.
FDA makes certain to note that the newly finalized guidance does not add any new regulatory requirements for medical devices and does not change the agency’s standards for determining substantial equivalence under the 510(k) pathway.
While FDA says that the benefit-risk profile of a new device does not need to be the same as its predicate to be considered substantially equivalent, the agency notes that a benefit-risk assessment should be carried out in certain circumstances when the benefit-risk profile is different between the devices.
“Such assessments may aid in the [substantial equivalence] SE evaluation by assessing whether the new device is ‘as safe and effective’ as the predicate device,” FDA writes, noting that performance data may be warranted when there are different technological characteristics between the new and predicate device.
The guidance also provides input on how FDA assesses different aspects of benefits and risks of devices.
For benefits, FDA details how it assesses magnitude of the benefits, the probability of a patient experiencing one or more benefit(s), and the duration of effect(s).
For risks, FDA says it 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.
Additionally, the guidance provides discussion of other factors to consider when evaluating the benefit-risk profile of a device, such as the level of uncertainty for a device, considerations for innovative technologies and patients’ tolerance for risk.
, Federal Register Notice