Safe and effective medical devices--everyone's responsibility.

Health care professionals frequently ask questions about how medical devices reach the market. These questions stem partly from their concerns about the "lengthiness" of the process. Because there appear to be some misconceptions about the process as required by law, nurses and physicians may find it useful to understand how the Food and Drug Administration (FDA) enforces its laws, how it works with user communities to identify trends and problems with medical devices, and how it develops and implements educational programs to complement its enforcement responsibilities. The purpose of this article, therefore, is to explain the FDA's role in regulating medical devices, the responsibilities of manufacturers in complying with the laws which regulate getting safe and effective devices to market, and the role of health care professionals in reporting adverse incidents to the FDA to ensure the safe and effective use of this equipment.