Sec. 202. Definitions
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Section 737 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379i ) is amended— by redesignating paragraphs
(8)through
(13)as paragraphs
(9)through (14), respectively; by inserting after paragraph
(7)the following new paragraph: The term de novo classification request means a request made under section 513(f)(2)(A) with respect to the classification of a device. ; in subparagraph
(D)of paragraph
(10)(as redesignated by paragraph (1)), by striking and submissions and inserting submissions, and de novo classification requests ; and in paragraph
(11)(as redesignated by paragraph (1)), by striking 2011 and inserting 2016 . Section 714(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379d–3(b)(1) ) is amended by striking 737(8) and inserting 737(9) .
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U.S. Code
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- 21 USC 379d–3(b)(1)
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