The Safe Medical Devices Act of 1990: are hospitals ready to deal with the FDA?

The Safe Medical Devices Act of 1990, long anticipated by regulatory affairs and compliance professionals in the medical device manufacturing industry, was signed by President George Bush on November 28, 1990. The law will significantly alter the structure of medical device regulatory mechanisms, and will expand the scope of the FDA's activities. The new medical device legislation sets requirements for hospitals as well as industry.