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The FDA approval process is not as stringent for devices as it is for drugs. To assess the quantity and quality of evidence that informs approval of high-risk cardiovascular devices, investigators examined FDA summaries of safety and effectiveness data for all such devices approved from 2000 through 2011.
In 121 device summaries, 203 supporting clinical studies were cited. Comparators for the 353 primary endpoints were as follows:
Active control, 40%
Historical control, 13%
Objective performance criteria or goal, 26%
No control, 22%
Approval of only 48% of devices was based on at least one primary endpoint with an active control, and 35% of devices were approved without any control data (see table).
