Hi Covers,
My company has selected a predicate device that was just recently recalled (Class 2 recall per FDA) because it doesn't meet its specifications. Unfortunately, much testing has already been done. Can this device still be used as a viable predicate for a 510(k) submission? There is a performance standard for these devices so the plan is to compare the new device to the performance standard and cite the specifications from the 510(k) of the predicate device to demonstrate substantial equivalence. Is this reasonable?
My company has selected a predicate device that was just recently recalled (Class 2 recall per FDA) because it doesn't meet its specifications. Unfortunately, much testing has already been done. Can this device still be used as a viable predicate for a 510(k) submission? There is a performance standard for these devices so the plan is to compare the new device to the performance standard and cite the specifications from the 510(k) of the predicate device to demonstrate substantial equivalence. Is this reasonable?