[zomg]

FDA clearance only means a company can legally market the device.

additionally, product testing != human trials. they are two very different things.

final product testing is called "design verification and validation" (aka dV+V) where a statistically significant number of devices are tested against several different categories.

human trials can run the gauntlet from a small IDE studies to phase I through IV.

the drug approval process is MUCH different than the medical device process.