Design Controls
Design Controls are a set of FDA-mandated practices required for the development of medical devices, as specified in 21 CFR 820.30. These controls ensure that the design and development process consistently results in devices that meet user needs, intended uses, and regulatory requirements.
Key components of design controls include:
- Design planning
- Design inputs (user needs and regulatory requirements)
- Design outputs (specifications, drawings)
- Design verification (confirming that design outputs meet inputs)
- Design validation (confirming that the final product meets user needs in a real-world environment)
- Design reviews
- Design transfer (moving from development to manufacturing)
Implementing design controls is critical for ensuring device safety and effectiveness.