1983
HR 3590 EAS/PP
applying subsections (a) and (b) of section 52 of
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such Code to this section, section 1563 of such
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Code shall be applied without regard to sub-
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section (b)(2)(C) thereof.
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(d) M
EDICAL
D
EVICE
S
ALES
.--For purposes of this
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section--
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(1) I
N
GENERAL
.--The term ``medical device
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sales'' means sales for use in the United States of any
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medical device, other than the sales of a medical de-
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vice that--
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(A) has been classified in class II under sec-
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tion 513 of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 360c) and is primarily sold
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to consumers at retail for not more than $100
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per unit, or
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(B) has been classified in class I under such
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section.
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(2) U
NITED
STATES
.--For purposes of para-
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graph (1), the term ``United States'' means the several
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States, the District of Columbia, the Commonwealth
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of Puerto Rico, and the possessions of the United
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States.
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(3) M
EDICAL DEVICE
.--For purposes of para-
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graph (1), the term ``medical device'' means any de-
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vice (as defined in section 201(h) of the Federal Food,
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