Device standards: the view from the FDA.

This paper constitutes an overview of FDA's functions and activities, offering a brief introduction to the Medical Device Amendments, and performance standard requirements from FDA's point of view. It discusses the agency's voluntary standards policy and the required conditions for deferral of mandatory standards. This paper also describes the Medical Device Standards Survey, and the role of the clinical engineer in standards development. It lists new Problem Definition Studies of the Bureau of Medical Devices which represent the first step in the new standards development process.