DEFINITIONS.

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)”.