The US Food and Drug Administration (FDA) review of new medical devices attempts to balance access to new and useful technology alongside determinations of “reasonable assurance of safety and effectiveness.” Most reviewed devices receive clearance for marketing through the 510(k) pathway, the guiding principle of which is establishing substantial equivalence between a new device under consideration and a similar predicate device that has previously been authorized for market. This standard was developed both to eliminate undue burden for device manufacturers bringing medium-risk devices to market and to acknowledge practical resource limitations of the FDA, which evaluates approximately 30 devices a year in the more thorough premarket approval process but clears about 3000 devices annually via the 510(k) pathway.
Source: JAMA Online First