Given the Food and Drug Administration’s (FDA) increased findings for companies that must comply to CFR 21 Part 820—“Quality system,” it’s curious that the oversight body has not offered much guidance about product design control, particularly concerning sections 820.30 and 820.40 of the regulation. Even in the FDA’s expanded document, “Design Control Guidance for Medical Device Manufacturers,” there’s no mention of controlling the device life cycle.

An important distinction and critical element of any design control that defines a product life cycle (PLC) is that it can play a critical role during a medical device audit or for demonstrating design-control compliance. Developing a PLC in tandem with a solid product development process (PDP) provides the necessary cornerstones for complete design-control and device-management compliance.

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