The FDA intended to ensure that good quality assurance practices are incorporated while designing medical devices to assure consistency with quality system requirements worldwide. The FDA effected changes to Current Good Manufacturing Practice stipulations by including them in Quality System Regulation 21 CFR Part 820. One of the most significant elements of the change is the inclusion of design controls.
At a large level, this regulation by the FDA requires establishment of proposed use and design inputs, design plan and consistent design evaluations throughout the process. Design outputs should conform to design inputs through design verification and validation. The design should be translated into manufacturable specifications and entire process must be clearly documented in a design history file. The goal of design controls needs manufacturers to adhere to a methodologically sound process for creating a medical device to enhance its probability of reaching an acceptable level of safety and efficacy.