I know what you’re thinking. You’ve got a medical device prototype that the FDA has categorized as Class I. You’re ready to push forward to manufacturing or marketing the device, since there are no formal requirements for design controls. “So why would I waste time on design controls?”

The fact is that, regardless of regulatory requirements, design controls are massively important to developing safer devices that fulfill user needs and improve the quality of life.

Don’t believe me? Here are three reasons you still should perform design controls, even if they aren’t required for compliance.

Factoring in exceptions to FDA design-control exemptions

The FDA mandates design controls in its quality system regulation (QSR) 21 CFR Part 820.30 as part of its current good manufacturing processes (cGMP). The regulation also states that design controls are required for all Class II and Class III devices, and requires manufacturers to establish, maintain, and document procedures for design controls.

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