Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.

FDA guidance also makes an explicit link between design control and risk management, highlighting the essential role of both in product development.

Below, we explore the basics of design controls and how to ensure FDA compliance by linking them in the quality management system (QMS).

What are design controls?

Design controls are FDA-mandated quality procedures to ensure that medical devices meet user needs, intended uses, and specified requirements. Design controls help identify issues earlier in the product development process so they can be corrected prior to production. They also enhance visibility throughout the design process, reducing costs and increasing productivity while facilitating better communication among the teams involved.

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