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If reimbursement is already available for a predicate device, a 510(k) clearance is most appropriate, because it is faster and more predictable, although it limits the potential for higher payment.
Mylan will pay $465 million to settle claims that the company misclassified its epinephrine auto-injector EpiPen for the Medicaid Drug Rebate program, allowing it to pay lower reimbursement rate to states for almost a decade.