ABSTRACT
Design control, as a requirement by the FDA, became part of the new Quality System Regulation placed in effect on June 1, 1997. The 12-month time span from June 1, 1997, to June 1, 1998, was called the “transition period.” During that period, design control was not used as an enforcement tool if the manufacturers could show they were taking “reasonable steps” to come into compliance. The actual first step many manufacturers took was to understand the regulation and prepare themselves for the development and the adoption of new quality systems. This step was a major change to many medical device manufacturers. Design control became an enforcement tool on June 1, 1998.
