Every domestic manufacturer, specification developers, foreign manufacturers / exporters or U.S. representatives of foreign manufacturers exporters trying to market their device in US shall submit 510(k). This will also be applicable for repackers or relabelers who make labeling changes or whose operations significantly affect the device. Therefore, it is very important for above mentioned stakeholders to know in detail about 510(k) submission.
A 510(k) is a premarket submission made to FDA which requires you to demonstrate that your medical device is substantially equal to the another legally US marketed device. Substantial equivalence shall be demonstrated by proving that your medical device is as safe and effective as the predicate device.
What is Premarket Notification 510 (k)?
The term “Predicate” is used to represent the medical device(s) legally marketed in US, to which equivalence is drawn during the 510(k) submission.