Zdrowie i gospodarka · 29/08/2000

Postmarket Surveillance

The Food and Drug Administration (FDA) is proposing to implement the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the FDA Modernization Act of 1997 (FDAMA). The purpose of this proposed rule is to provide for the collection of useful data or other information necessary to protect the public health and to provide safety and effectiveness information about devices.