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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1943 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                S. 1943

  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 SENATE OF THE UNITED STATES

                            December 5, 2011

Mr. Brown of Massachusetts (for himself and Ms. Ayotte) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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.--
            (1) De novo classification.--Section 513(f)(2)(A) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(2)(A)) 
        is amended--
                    (A) by striking ``(A) Any person'' and inserting 
                ``(A)(i) Any person''; and
                    (B) 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).''.
            (2) Option for initial classification.--Section 513(f)(2) 
        of the Federal Food, Drug, and Cosmetic Act (22 U.S.C. 
        360c(f)(2)) is amended--
                    (A) by redesignating subparagraph (C) as 
                subparagraph (D); and
                    (B) by inserting after subparagraph (B) the 
                following:
    ``(C)(i) Any person that is required to submit a report under 
section 510(k) with respect to a device, and determines that there is 
no legally marketed device upon which to base a determination of 
substantial equivalence (as such term is defined in subsection (i)), 
may submit a request for initial classification of the device under 
this subparagraph. Subject to clause (ii), the Secretary shall classify 
the device under the criteria set forth in subparagraphs (A) through 
(C) of subsection (a)(1). The person submitting the request for 
classification under this subparagraph may recommend to the Secretary a 
classification for the device.
    ``(ii) The Secretary may decline to undertake a classification 
request submitted under clause (i) when the Secretary identifies a 
legally marketed device that would permit a determination of 
substantial equivalence 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>
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