ABSTRACT
Andrew Lowery, Judy Strojny, and Joseph Puleo Division of Small Manufacturers Assistance Office of Health and Industry Programs CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
December 1996
3. Design Controls
Introduction
T h e Safe M ed ica l D evices A ct o f 1990 added design va lidation requ irem ents to
the GMP requ irem ents in section 5 20 (f) o f T h e Act. Section 820.30 o f the Qual ity System (Q S ) regulation lists the design con tro l requ irem ents that m anufac turers should satis fy to be in com pliance. Th is chapter describes design con tro ls and p rov id es gu idance to assist m anufacturers in com plying w ith de sign con tro l requ irem ents.
