A new FDA draft guidance
lays out the steps it uses to assess risks and benefits for “substantial equivalency” of devices when they have different technological characteristics than their predicates.
FDA Provides Guidance On 510(k) Devices With Different Technological Characteristics
FDA issues a draft guidance July 15 describing how it weighs the risks and benefits to prove substantial equivalency in 510(k) devices when the new product’s technological characteristics differ from its predicate device.