What is the meaning of ‘substantially equivalent’ for FDA approval?
To receive FDA approval on a new device intended for human use, a premarket submission called a 510k must be made to the FDA. This must demonstrate that the device is substantially equivalent to a legally marketed device, meaning that it is just as safe and effective.
According to the FDA, a device is considered “substantially equivalent” if the following criteria are met:
Has the same intended use as the predicate device; and
Has the same technological characteristics as the predicate;OR
Has the same intended use as the predicate; and
Has different technological characteristics and does not raise different questions of safety and effectiveness; and
The device is demonstrated to be as safe and effective as the legally marketed device
Once this information has been submitted to the FDA, the FDA will determine whether the device is safe and effective through a thorough review process, including evaluation of performance data and technological characteristics. In the US, a device may not be marketed until the FDA determines that substantial equivalence is present.(Tick)
Definition. A predicate device is a medical device that may be legally marketed in the U.S. and used as a point of comparison for new medical devices seeking approval through FDA's 510(k) premarket clearance pathway.
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