Design Input is defined by the FDA as the physical and performance requirements of a device that are used as a basis for device design. It is essentially the stakeholder requirements, systems requirements and allocated component requirements. This is a subset of the Design History File

In practice, it is necessary to discriminate the different types of requirement and design information and to understand the risk if this is not done.

FDA Statements

• 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 a designated individual(s).
• The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

References

• FDA Design Control Guidance for Medical Device Manufacturers, Section C:
  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm#_Toc382720785
  • PDF available on that page: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf
• Section 820.30(c) of FDA Quality System Regulation
• ISO 9001:1994
• ISE/DIS 13485 Section 4.4.4 Design input

Mapping

The following process elements satisfy this objective:

• Stakeholder Requirements Specification
• Systems Requirements Specification
• Vision
• Interface Control Document
• Subsystem Requirements Specification 

More information:

• Architectural Design - Use-Case Based
• Real-Time Architectural Design