The design controls regulation (21 CFR 820.30) has its roots in the “Current Good Manufacturing Practices” (CGMP’s) as authorized in section 520(f) of the Food and Drug Administration (FDA) Act which became effective December 18, 1978. (FDA CGMP, 2014) The initial intent of these CGMP’s was to ensure that commercialized medical devices would experience minimal device failures that may lead to patient injury or death. During the following ten years after 1978, the FDA realized that a significant number of device failures were occurring due to design defects.
Quality Systems Regulation Preamble States:
“Since early 1984, FDA has identified lack of design controls as one of the major causes of device recalls. The intrinsic quality of devices, including their safety and effectiveness, is established during the design phase. Thus, FDA believes that unless appropriate design controls are observed during preproduction stages of development, a finished device may be neither safe nor effective for its intended use. The “Safe Medical Device Act” (SMDA) provided FDA with the authority to add preproduction design controls to the device CGMP regulation. Based on its experience with administering the original CGMP regulation, which did not include preproduction design controls, the agency was concerned that the original regulation provided less than an adequate level of assurance that devices would be safe and effective. Therefore, FDA has added general requirements for design controls to the device CGMP regulation for all class III and II devices and certain class I devices.” (FDA Preamble, 2015)
In 1989 FDA published a notice of availability for design control recommendations which was titled, “Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers” (Hooten, 1996). This was an early indication to the industry that controls during the development of medical devices was well on its way to becoming a reality. A year later the “Safe Medical Device Act of 1990” was introduced and became law and section 520(f) was amended which added “preproduction design validation” controls to the device GMP regulation. Over the next six years the design controls regulation was developed and refined. “After an extensive effort, the part 820 revision was published on October 7, 1996 and went into effect June 1, 1997.” (FDA CGMP, 2014) Design controls became 21 CFR 820.30 (subpart C) as part of the Quality System Regulation.