I 112th CONGRESS 1st Session H. R. 3203 IN THE HOUSE OF REPRESENTATIVES October 14, 2011 Mr. Bilbray (for himself, Mrs. Blackburn, Mr. Lance, Mr. Burgess, Mr. Paulsen, Mrs. Capps, Mr. Guthrie, Mr. Hunter, Mr. Dent, Mr. Stearns, Mr. Latta, and Mr. Shimkus) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend section 513 of the Federal Food, Drug, and Cosmetic Act to expedite the process for requesting de novo classification of a device.

1.

Short title

This Act may be cited as the Novel Device Regulatory Relief Act of 2011.

2.

Modification of de novo application process

(a)

In general

Section 513(f)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(2)(A)) is amended— (1)by striking (A) Any person and all that follows through to classify and inserting (A)(i) Any person introducing or delivering for introduction into interstate commerce for commercial distribution a device intended for human use may request that the Secretary classify; and (2)by inserting after classification. the following: (ii)A person may submit a request under clause (i) without regard to whether such person has received written notice of classification into class III under paragraph (1). . (b)

Conforming amendment

Section 513(f)(1) of such Act (21 U.S.C. 360c(f)(1)) is amended— (1)in subparagraph (A), by striking or at the end; (2)in subparagraph (B), by striking the period and inserting ; or; and (3)by inserting after subparagraph (B) the following: (C)the device is classified pursuant to a request submitted under paragraph (2). .