[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 2193 Introduced in Senate (IS)]

112th CONGRESS
  2d Session
                                S. 2193

 To require the Food and Drug Administration to include devices in the 
  postmarket risk identification and analysis system, to expedite the 
 implementation of the unique device identification system for medical 
                    devices, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 15, 2012

   Mr. Merkley (for himself, Mr. Grassley, Mr. Bennet, and Mr. Kohl) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To require the Food and Drug Administration to include devices in the 
  postmarket risk identification and analysis system, to expedite the 
 implementation of the unique device identification system for medical 
                    devices, and for other purposes.

    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 ``Ensuring Safe Medical Devices for 
Patients''.

SEC. 2. ACTIVE POSTMARKET RISK IDENTIFICATION AND ANALYSIS.

    (a) Records and Reports on Devices.--Section 519 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended by inserting 
after subsection (c) the following:
    ``(d) Inclusion of Devices in the Postmarket Risk Identification 
and Analysis System.--Not later than 90 days after the date of 
enactment of the Ensuring Safe Medical Devices for Patients, the 
Secretary shall amend the procedures established and maintained under 
section 505(k)(3)(C) in order to expand the postmarket risk 
identification and analysis system established under such section to 
include and apply to devices in a comparable manner as such system 
includes and applies to drugs. The Secretary shall ensure that such 
amendments to the procedures shall give priority for inclusion in the 
postmarket risk identification and analysis system to class III and 
class II devices that are implantable, life-supporting or life-
sustaining, or pose significant risk to users.''.
    (b) Unique Device Identification System.--Section 519(f) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) is amended--
            (1) by striking ``The Secretary shall promulgate'' and 
        inserting ``Not later than December 31, 2012, the Secretary 
        shall issue final''; and
            (2) by adding at the end the following:
``The Secretary shall implement the unique device identification system 
under this subsection not later than 1 year after the date on which the 
final regulations are issued.''.
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