MANUFACTURER RELUCTANCE TO SUPPLY IDE NUMBERS TO CLINICAL INVESTIGATORS DELAYS HCFA REIMBURSEMENT, FDA SAYS; FIRST CYCLE IDE APPROVAL RATE AT 60%
This article was originally published in The Gray Sheet
Executive SummaryManufacturers must be willing to provide clinicians conducting device studies with investigational device exemption application numbers in order for the devices to receive Medicare reimbursement, FDA reminds study sponsors in a recent letter to device industry groups.
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