These two partsneed each other:
FDA has a new blog post titled:A CDRH Priority: Clinical Trials in the U.S.(1) in part it says:
Innovative medical products begin with clinical trials and before a clinical trial of a significant risk device begins in the U.S., a researcher, among other things, must apply for and receive FDAs approval through the Investigational Device Exemption (IDE) process. The FDA reviews IDE applications to determine whether the sponsor has provided enough information to be sure that the study does not present an unreasonable risk to its participants. FDA takes into account the qualifications of the clinical investigators, informationabout the device, the design of the clinical investigation, the condition for which the device is to be investigated, and the health status of the participating patients.
thePerfectD just a few day before postedWhy Clinical Trials Matter To People With Diabetes(2)in part it says:
Clinical trials means better drugs and devices.
Better drugs and devices mean better treatments.
Better treatments mean longer, healthier lives.
Longer, healthier lives means more time with the people you love.
Clinical trials = love.