Medical Device Safety Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to provide that provisions preempting state and local requirements for medical devices intended for human use shall not be construed to modify or otherwise affect any action for damages or the liability of any person under state law. Makes this Act effective as if it were included in the Medical Device Amendments of 1976 and applicable to any civil action pending or filed on or after the date of enactment of this Act.
[Congressional Bills 110th Congress]
[From the U.S. Government Printing Office]
[S. 3398 Introduced in Senate (IS)]
110th CONGRESS
2d Session
S. 3398
To amend the Federal Food, Drug, and Cosmetic Act with respect to
liability under State and local requirements respecting devices.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 31, 2008
Mr. Reid (for Mr. Kennedy (for himself, Mr. Leahy, Mr. Dodd, Mr.
Harkin, Ms. Mikulski, Mr. Bingaman, Mrs. Murray, Mr. Reed, Mrs.
Clinton, Mr. Obama, Mr. Sanders, Mr. Brown, and Mr. Whitehouse))
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to
liability under State and local requirements respecting devices.
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 ``Medical Device Safety Act of 2008''.
SEC. 2. LIABILITY UNDER STATE AND LOCAL REQUIREMENTS RESPECTING
DEVICES.
(a) Amendment.--Section 521 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360k) is amended by adding at the end the following:
``(c) No Effect on Liability Under State Law.--Nothing in this
section shall be construed to modify or otherwise affect any action for
damages or the liability of any person under the law of any State.''.
(b) Effective Date; Applicability.--The amendment made by
subsection (a) shall--
(1) take effect as if included in the enactment of the
Medical Device Amendments of 1976 (Public Law 94-295); and
(2) apply to any civil action pending or filed on or after
the date of enactment of this Act.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S7953-7954)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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