124 STAT. 863 PUBLIC LAW 111–148—MAR. 23, 2010 calendar year the date determined by the Secretary, but in no event later than September 30 of such calendar year. (b) DETERMINATION OF FEE AMOUNT.— (1) IN GENERAL.—With respect to each covered entity, the fee under this section for any calendar year shall be equal to an amount that bears the same ratio to $2,000,000,000 as— (A) the covered entity’s gross receipts from medical device sales taken into account during the preceding cal- endar year, bear to (B) the aggregate gross receipts of all covered entities from medical device sales taken into account during such preceding calendar year. (2) GROSS RECEIPTS FROM SALES TAKEN INTO ACCOUNT.— For purposes of paragraph (1), the gross receipts from medical device sales taken into account during any calendar year with respect to any covered entity shall be determined in accordance with the following table: With respect to a covered entity’s aggregate gross receipts from medical device sales dur- ing the calendar year that are: The percentage of gross receipts taken into account is: Not more than $5,000,000 ....................... 0 percent More than $5,000,000 but not more than $25,000,000. 50 percent More than $25,000,000 ............................. 100 percent. (3) SECRETARIAL DETERMINATION.—The Secretary shall cal- culate the amount of each covered entity’s fee for any calendar year under paragraph (1). In calculating such amount, the Secretary shall determine such covered entity’s gross receipts from medical device sales on the basis of reports submitted by the covered entity under subsection (f) and through the use of any other source of information available to the Sec- retary. (c) COVERED ENTITY.— (1) IN GENERAL.—For purposes of this section, the term ‘‘covered entity’’ means any manufacturer or importer with gross receipts from medical device sales. (2) CONTROLLED GROUPS.— (A) IN GENERAL.—For purposes of this subsection, all persons treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 or subsection (m) or (o) of section 414 of such Code shall be treated as a single covered entity. (B) INCLUSION OF FOREIGN CORPORATIONS.—For pur- poses of subparagraph (A), in applying subsections (a) and (b) of section 52 of such Code to this section, section 1563 of such Code shall be applied without regard to subsection (b)(2)(C) thereof. (d) MEDICAL DEVICE SALES.—For purposes of this section— (1) IN GENERAL.—The term ‘‘medical device sales’’ means sales for use in the United States of any medical device, other than the sales of a medical device that— (A) has been classified in class II under section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Applicability.
