### Question
How is the term patient-reported outcome defined?


### Answer
The term **patient-reported outcome** is defined in *21 U.S.C. § 357* as the following:

> a measurement based on a report from a patient regarding the status of the patient's health condition without amendment or interpretation of the patient's report by a clinician or any other person

#### Citation:
  - *21 U.S.C. § 357*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

