Regulatory Terms Starting With U

2 terms in the U index.

• UDI (Unique Device Identification)

  UDI is the unique numeric or alphanumeric code FDA requires on medical device labels to identify a device through its distribution and use, built from a fixed device identifier plus a conditional production identifier.

• Umbrella Trial

  An umbrella trial is a master protocol design that enrols a single disease and assigns participants to different investigational therapies by molecular subtype, running those arms as sub-studies under one governing framework.