21 CFR 820.30

21 CFR 820.30 is the section of the FDA’s Quality System Regulation (QSR) that specifically outlines design controls for medical device manufacturers. It mandates the processes manufacturers must follow during the design and development of medical devices to ensure their safety and effectiveness.
The regulation requires companies to:

• Develop a Design and Development Plan
• Establish Design Inputs based on intended use and user needs
• Define Design Outputs (e.g., specifications, drawings)
• Conduct Design Verification to ensure outputs meet inputs
• Perform Design Validation to ensure the device meets the intended use under real or simulated conditions
• Hold formal Design Reviews at key stages of development
• Document Design Transfer to manufacturing

Failure to comply with 21 CFR 820.30 can result in regulatory penalties, product recalls, or FDA warning letters.

These terms are all essential in maintaining regulatory compliance within FDA-regulated industries, ensuring product safety, and protecting public health.