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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3208 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 3208

To reaffirm the Safe Medical Devices Act of 1990 by requiring that the 
 Secretary of Health and Human Services establish a schedule and issue 
regulations as required under section 515(i) of the Federal Food, Drug, 
               and Cosmetic Act, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            October 14, 2011

  Mr. Shimkus (for himself, Mr. Gingrey of Georgia, Mr. Guthrie, Mr. 
    Lance, Mrs. Blackburn, Mr. Rogers of Michigan, Mr. Bilbray, Mr. 
Burgess, Mr. Barton of Texas, Mr. Paulsen, Mr. Cassidy, and Mr. Latta) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
To reaffirm the Safe Medical Devices Act of 1990 by requiring that the 
 Secretary of Health and Human Services establish a schedule and issue 
regulations as required under section 515(i) of the Federal Food, Drug, 
               and Cosmetic Act, 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 ``Patients Come First Act of 2011''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) Under the Safe Medical Devices Act of 1990 (Public Law 
        101-629), Congress amended section 515 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360e) to require the Food and 
        Drug Administration to reclassify preamendment class III 
        devices to a lower class or to require them to go through the 
        premarket approval process.
            (2) The Food and Drug Administration still has not complied 
        with the mandate of Congress under such Act, jeopardizing the 
        health of the Nation's patients.

SEC. 3. ESTABLISHMENT OF SCHEDULE AND PROMULGATION OF REGULATION.

    (a) Establishment of Schedule.--Not later than 90 days after the 
date of enactment of this Act, the Secretary of Health and Human 
Services shall establish the schedule referred to in section 515(i)(3) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(i)(3)).
    (b) Regulation.--Not later than one year after the date that the 
schedule is established under such section 515(i)(3) (as required by 
subsection (a)) the Secretary shall issue a final regulation under 
section 515(b) of such Act for each device that the Secretary requires 
to remain in class III through a determination under section 515(i)(2) 
of such Act.

SEC. 4. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 518 (21 U.S.C. 360h) the following:

``SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.

    ``(a) In General.--The Secretary shall--
            ``(1) establish a program to routinely and systematically 
        assess information relating to device recalls and use such 
        information to proactively identify strategies for mitigating 
        health risks presented by defective or unsafe devices;
            ``(2) clarify procedures for conducting device recall audit 
        checks to improve the ability of investigators to perform those 
        checks in a consistent manner;
            ``(3) develop detailed criteria for assessing whether a 
        person performing a device recall has performed an effective 
        correction or action plan for the recall; and
            ``(4) document the basis for each termination by the Food 
        and Drug Administration of a device recall.
    ``(b) Assessment Content.--The program established under subsection 
(a)(1) shall, at a minimum, identify--
            ``(1) trends in the number and types of device recalls;
            ``(2) devices that are most frequently the subject of a 
        recall; and
            ``(3) underlying causes of device recalls.''.
                                 <all>
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