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
Design inputs Physical and performance requirements derived from intended use, user needs, and risk analysis (per ISO 14971)
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.
Official resources
For Class I devices, design controls apply only if the device is intended for a use that is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk. Examples include Class I pacemakers and critical diagnostic devices used for patient monitoring. Most Class I devices exempt from 510(k) notification are also exempt from design control requirements, though they remain subject to CAPA, complaint handling, and MDR procedures.