Mr. Chair, the regulations allow the departments to make sure that the devices are safe, effective and of good quality before they are marketed. This is a premarket evaluation—a scientific evaluation that is being conducted by government scientific individuals.
The requirements for breast implants are the ones for the higher-risk devices, the class IV devices. We have expertise at the department for conducting this premarket scientific evaluation. We also have the expertise, once the devices are marketed, to continue monitoring their safety and effectiveness on the market.