Sec. 202. DEFINITIONS
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/statute-compilations/comps-15234/sec-202A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 202 DEFINITIONS ###
(a)In general Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i) is amended— ####
(1)by redesignating paragraphs
(8)through
(13)as paragraphs
(9)through (14), respectively; ####
(2)by inserting after paragraph
(7)the following new paragraph: > > #### “(8) > > The term ‘**de novo classification request**’ means a request made under section 513(f)(2)(A) with respect to the classification of a device.” > ; ####
(3)in subparagraph
(D)of paragraph
(10)(as redesignated by paragraph (1)), by striking “**and submissions**” and inserting “**submissions, and de novo classification requests**”; and ####
(4)in paragraph
(11)(as redesignated by paragraph (1)), by striking “**2011**” and inserting “**2016**”. ###
(b)Conforming amendment 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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