CFR 21-820.30d - Design Output

Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design Output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented.

Attention points

• Design output control must ensure that each describes initial through final design output is documented, reviewed ad approved by approproate management.
• The FDA expects that the more complex the process is, the more documentation is associated with control of the process.
• Items that must be documented are:
  • Output documents for all new design or development activities
  • Modifications to a new or existing regulated product
  • The intented use of each device, including user and patient needs

The output team is usually tasked to do the following:

• Create a Functional Model of the device
• Partition the design apprioately to facilitate design feasibility
• Identify critical design outputs
• Continue development and complete the Risk Analisys by appropriate Risk Management Procedures
• Finalize and approve the Functoinal Design Specification created by the project team
• Finish Detailed Design Documents
• Define physical design specifications including architectural requirements of the device, its subassemblies and components
• Define packaging specifications
• Implement Change Control Procudures for all activities in the design output specifications stage
• Create a master Verification Plan and Test Plans use to verify that the design conforms to its safety & reliability requirements
• Review and approve all documents used to implement the preding activities
• Prepare for a Formal Design Review and approval at the completion of the design process.

Mechanisms to document control over output specifications might include the following:

• A Design Input Requirements Control Matrix
• Detailed input documents