Design output is the result derived from each step of design process efforts as well as at the end of entire design process effort. A complete design process output will have the device, packaging and labeling information along with the device master record. Design output provides a strong description of all the ingredients of a device including drawings, components, parts, materials, specifications, pieces, manufacturing instructions, and inspection procedures. FDA mandates to establish and maintain processes for defining and documenting design output so that it allows an adequate evaluation of design input requirements for manufacturers under FDA 820.30(d).
