FDA Releases Final Guidance on Benefit-Risk Factors for 510(k) Submissions

The FDA released a final guidance for 510(k) applicants on how to show substantial equivalence for devices with benefit-risk profiles that differ technologically from the devices on which they are based.

New devices don’t need to have the same benefit-risk profiles as their predicate devices to be “substantially equivalent,” the FDA said, but in those situations, a benefit-risk assessment should be made to determine if the new device is as safe and effective as its predicate version.

When comparing the benefits and risks of a new device to a predicate device, there might be variability in the type or extent of benefits and/or risks,” the FDA said. When this happens, the agency evaluates benefit-risk differences.