DEFINITIONS.

SEC. 2002. DEFINITIONS. Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i) is amended— (1) in paragraph (9)— (A) in the matter preceding subparagraph (A), by striking “and premarket notification submissions” and inserting “premarket notification submissions, and de novo classification requests”; (B) in subparagraph (D), by striking “and submissions” and inserting “submissions, and de novo classification requests”; (C) in subparagraph (F), by striking “and premarket notification submissions” and inserting “premarket notification submissions, and de novo classification requests”; (D) in each of subparagraphs (G) and (H), by striking “or submissions” and inserting “submissions, or requests”; and (E) in subparagraph (K), by striking “or premarket notification submissions” and inserting “premarket notification submissions, or de novo classification requests”; and (2) in paragraph (11), by striking “2016” and inserting “2021”.