### Question
How is the term eligible patient defined?


### Answer
The term **eligible patient** is defined in *21 U.S.C. § 360bbb* as the following:

> a patient—


(A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations))

#### Citation:
  - *21 U.S.C. § 360bbb*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part E-General Provisions Relating to Drugs and Devices**

