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FDA’s “Intended Use” and “Indications for Use”

Depending on what type of device you are writing the Indications for Use statement (diagnostic or therapeutic) there should be several specific elements to your statement. 

For instance:

Levels of Specificity for diagnostic medical devices:

• Identification or measurement of a physical parameter (e.g., image, heart rate) or biochemical parameter (e.g., analyte)
• Identification of a new or specific target population (e.g., women, children of a certain age range) or anatomical location (e.g., MR of the brain)
• Identification of the clinical use of the measurement (e.g., diagnosis, screening)
• Identification of or implication of an effect on the clinical outcome (e.g., screening mammography reduces breast cancer mortality)

If your device is diagnostic in nature it should have at a minimum these specific descriptions. 

For therapeutic devices:

 Levels of Specificity for therapeutic (including preventive) medical devices: 

• Identification of function (e.g., cut)
• Identification of tissue type (e.g., soft tissues)
• Identification of an organ system (e.g., GI tract ) or
  Identification of a specific organ (e.g. liver)
• Identification of a particular disease entity (e.g., resection of hepatic metastases) or target population
• Identification of an effect on clinical outcome (e.g., use of medical device improves the rate of durable complete remissions with chemotherapy)

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