Table 7.

Characteristics of Devices that May Qualify as “Custom” Vs. “Customized”

•Unusual size: The device has been approved for a wide range of sizes expected to cover a whole patient population, but a patient presents who requires an unusual size outside of that range, and the manufacturer must create an individual size to fit the patient.

•Allergy: If a patient presents with an unusual sensitivity to material that is used in the approved version of the device, the manufacturer may need to create an individual device with special coating or other materials to meet the patient’s needs.

•Unusual patient disease state: an entirely new type of device is created for an individual patient.

•Physician need: a physician needs special instrumentation due to their individual characteristics (e.g., a surgeon missing a finger who needs special instruments or gloves).

•Medical facility need: a medical facility may require customized devices for use only in that office, such as special controls on all of its equipment that are not used at other facilities.