Patients Come First Act of 2011 - Directs the Secretary of Health and Human Services (HHS): (1) within 90 days after enactment of this Act, to establish the schedule required under the Federal Food, Drug, and Cosmetic Act for the promulgation of regulations requiring premarket approval for medical devices required to remain in class III; and (2) not later than one year after the schedule is established, to issue a final regulation for each such device.
Directs the Secretary to: (1) establish a program to 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 Food and Drug Administration (FDA) termination of a device recall.
[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>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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