Table 1.

FDA Approval Rates for Compassionate Use of Medical Devices

Year	With IDE	Without IDE
2012	99.19	98.11
2013	98.86	91.79
2014	99.54	99.01
2015	99.04	98.80

Values are %. See reference (5).

FDA = U.S. Food and Drug Administration; IDE = investigational device exemption.