Clinical Trials: What Executives Need to Know

Originally Published January/February 2001

Jeffrey N. Gibbs

Innovation is the lifeblood of the medical device industry. Medical device manufacturers must constantly develop new products and upgrade existing ones. However, while other industries can develop new products—such as computers and software—that can swiftly enter the marketplace unimpeded, new medical devices must pass through a narrow gate presided over by FDA. Getting by that gatekeeper often requires conducting clinical trials.

Not all new device marketing applications need to be supported by clinical data. Although many premarket notifications (510(k)s) do contain such data—particularly for newer types of products—most are not supported by human testing. Similarly, supplements to many premarket approval (PMA) applications do not require clinical data.