CFR 21-820.30c - Design Input

Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

Attention points

• Design inputs are often referred to as Requirements
• Among the activities that need to be documented are:
  • Intended use
  • User needs
  • Patient needs
  • A mechanism for addressing incomplete, ambigious or conflicting requirements
  • Design and development interfaces
• A good mechanism to control design input documentation is a Design Input Document Control Matrix

Attention points

Possible mechanisms to control input requirements include the following:

• A detailed Design Input Requirements Control Matrix
• Detailed input documents