The U.S. Food and Drug Administration (FDA) has issued a final guidance to help medical device manufacturers determine whether a new medical device is “substantially equivalent” to another medical device that has already been cleared for sale under the agency’s 510(k) premarket review program.
The ability to demonstrate that a new device is substantially equivalent to one that has already received FDA approval can significantly reduce the testing process required for the agency’s approval of that device. Manufacturers often seek to demonstrate substantial significance to a previously approved device in order to reduce the time and expense of preparing their device for a full 510(k) premarket review, enabling them to bring new devices to market more quickly.
Published in late September, the final guidance offers guidance on situations in which the benefit-risk profile of a new device is different from that of the predicate device for which the manufacturer is claiming substantial equivalence.
Like all guidance documents issued by the FDA, this guidance is solely intended to represent the agency’s current thinking on issue of substantial equivalence and does not have the force of law. However, it is likely to be extremely helpful to medical device manufacturers exploring possible pathways for approval under the 510(k) program.
