Design Controls
Who must have design controls?
Design controls under 21 CFR § 820.30 (QMSR) apply to manufacturers of Class II and Class III devices, and Class I devices intended for a use that is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk.
The seven design control elements
| Element | Description |
|---|---|
| Design and development planning | Written plan defining stages, responsibilities, interfaces |
| Design inputs | Physical and performance requirements derived from intended use and risk analysis (ISO 14971) |
| Design outputs | Specifications, drawings, production procedures that satisfy inputs |
| Design review | Formal, documented reviews at each design stage |
| Design verification | Objective evidence that design outputs meet inputs (e.g., bench testing, analysis) |
| Design validation | Objective evidence that the device meets user needs and intended use — typically includes clinical evaluation and/or usability testing |
| Design transfer | Procedures to translate design into production specifications |
| Design changes | Change control procedures with risk assessment and re-verification/re-validation |
Design History File (DHF)
The DHF is a compilation of records that describes the design history of a finished device. It must contain:
- All design control records
- Evidence that the device was developed in accordance with the approved design plan
- Records of design reviews, verifications, validations, and changes
The DHF is a primary target during FDA 510(k) review and facility inspections.