A device can be “cleared” by the FDA by demonstrating that it is “substantially equivalent” to a “predicate device”, which is a previously cleared or approved device. Does the current API support getting the predicate device for a given 510(k) clearance?
A device can be “cleared” by the FDA by demonstrating that it is “substantially equivalent” to a “predicate device”, which is a previously cleared or approved device. Does the current API support getting the predicate device for a given 510(k) clearance?