In vitro diagnostic (IVD) products drive a significant portion of clinical decision making today. IVDs assist in the identification, diagnosis and monitoring of disease. They play an ever-expanding role in the selection of appropriate therapeutic interventions in healthcare delivery with the advent of personalized medicine. These key products are a distinct class of medical devices regulated in the US by the Food and Drug Administration (FDA).
This course provides a basic overview of in vitro diagnostic medical devices with a focus on FDA’s regulatory requirements. It introduces key regulations and guidelines necessary for effective product development, explains what IVDs are and describes development and testing, getting a product to market, product review and FDA submission requirements.