### Question
How is the "eligible product" defined?


### Answer
The term **eligible product** is defined in *21 U.S.C. § 360bbb* as follows -

> a product that—


(A) is approved or cleared under this subchapter, conditionally approved under section 360ccc of this title, or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262]

#### 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**

