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.
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.