### Question
How does the law define rare disease or condition?


### Answer
Under *21 U.S.C. § 360ee*, **rare disease or condition** is defined as:

> (1) in the case of a drug, any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug, (2) in the case of a medical device, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical device for such disease or condition will be developed without assistance under subsection (a) of this section, and (3) in the case of a medical food, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical food for such disease or condition will be developed without assistance under subsection (a) of this section

#### Citation:
  - *21 U.S.C. § 360ee*
  - Heading: **CHAPTER 8-NARCOTIC FARMS > SUBCHAPTER V-DRUGS AND DEVICES > Part B-Drugs for Rare Diseases or Conditions**

