annual distribution number
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 360J — under this chapter (2 versions over time)
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.