by Laurence Grossman

This year marks the 100th anniversary of the Food and Drug Administration (FDA), making it the oldest consumer protection agency in the nation. FDA has regulatory authority over approximately one-quarter of the US economy. Each segment of this economy requires a different regulatory approach.
Engineering studies figure prominently in the Agency's approach to regulating medical devices. Engineering studies are used to supplement human trials, to allow trial design of smaller sizes, and to replace human trials entirely when appropriate. Typically if an engineering analysis can show that a new device is equivalent to an existing already approved device then marketing approval can be granted.
The Office of Science and Engineering Laboratories is the laboratory arm of FDA's Center for Devices and Radiological Health. This group of scientists has multiple purposes. They are heavily involved in the quest to supplement and replace human experience with engineering requirements. They provide the Agency with the ability to obtain independent data. They also serve as an expertise pool for breaking new technologies and a training ground for scientific staff within the Agency. Dr. Grossman will summarize several on-going project areas within the Office to serve as examples of how laboratory research can serve public health in a regulatory agency.