annual distribution number

Defined in 1 place of the United States Code.

During any calendar year, the number of such devices distributed during that year under each exemption granted under this subsection does not exceed the annual distribution number for such device. In this paragraph, the term “annual distribution number” means the number of such devices reasonably needed to treat, diagnose, or cure a population of 4,000 individuals in the United States. The Secretary shall determine the annual distribution number when the Secretary grants such exemption.

Source

2012–2016 21 U.S.C. § 360JFood and Drugs · General provisions respecting control of devices intended for human use · under this chapter

During any calendar year, the number of such devices distributed during that year under each exemption granted under this subsection does not exceed the annual distribution number for such device. In this paragraph, the term “annual distribution number” means the number of such devices reasonably needed to treat, diagnose, or cure a population of 8,000 individuals in the United States. The Secretary shall determine the annual distribution number when the Secretary grants such exemption.

Source

2016–present 21 U.S.C. § 360JFood and Drugs · General provisions respecting control of devices intended for human use · under this chapter