[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3203 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 3203

  To amend section 513 of the Federal Food, Drug, and Cosmetic Act to 
expedite the process for requesting de novo classification of a device.


_______________________________________________________________________


                    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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

SEC. 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).''.
                                 <all>