Preproduction quality assurance: quality intrinsic to design.

Abstract

The Safe Medical Devices Act of 1990 made important changes to the Federal Food, Drug, and Cosmetic Act's provisions governing medical devices and in vitro diagnostics. Not the least of these changes is the addition of preproduction design validation "including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device," under the good manufacturing practice (GMP) regulation. Combining this new law with the existing GMP regulation on manufacturing operations yields the beginning of total quality management (TQM).