by David DiPaola
Managing Director, DiPaola Consulting
With major advances in MEMS and nanotechnology and their proliferation into medicine, it is important to have a working knowledge of the critical steps in obtaining U.S. Food and Drug Administration (FDA) approval for commercialization. An understanding of the core elements and expedited review opportunities for medical devices provides entrepreneurs a key advantage in decision making, development and commercialization for the shortest time to market.
Many MEMS products intended for use with humans are considered medical devices under the FDA approval process. This includes products for diagnostics, monitoring, surgical and therapeutic applications. For a manufacturer to market or commercially distribute a medical device, it must first comply with the regulatory requirements of the FDA. The critical steps of this process are outlined in the flow chart below.