Some current requirements under the FDA medical device regulations

The Medical Device Amendments of 1976 define the increasingly important role of the FDA in the medical device manufacturer-user relationship. The new requirements imposed on the manufacturer, modifier and produce user must be implemented gradually. Guidance during this initial period is hard to come by, for many situations have not been clearly spelled out and tested. It is hoped that this article will shed some light on what has become an important legal and technical aspect of our profession.