H.R. 6381 (110th): Medical Device Safety Act of 2008

110th Congress, 2007–2009. Text as of Jun 26, 2008 (Introduced).

Status & Summary | PDF | Source: GPO

HR 6381 IH

110th CONGRESS

2d Session

H. R. 6381

To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.

IN THE HOUSE OF REPRESENTATIVES

June 26, 2008

Mr. PALLONE (for himself, Mr. WAXMAN, Mrs. CAPPS, Mr. WEINER, Mr. HINCHEY, Ms. SCHAKOWSKY, Mr. BRALEY of Iowa, Mr. DOYLE, Mr. TOWNS, Mr. STUPAK, Ms. SOLIS, Mr. GENE GREEN of Texas, Ms. SLAUGHTER, Mr. WELCH of Vermont, Ms. CASTOR, Mr. JOHNSON of Georgia, Mr. SCHIFF, Mr. MARKEY, Mr. ALLEN, Ms. ZOE LOFGREN of California, Mr. ROSS, Ms. BALDWIN, Ms. DELAURO, Mr. WEXLER, Mr. BOSWELL, Mr. DELAHUNT, Ms. ROYBAL-ALLARD, Mr. RUSH, Ms. WASSERMAN SCHULTZ, Ms. SUTTON, Mr. MCNERNEY, Mr. HASTINGS of Florida, Mr. EMANUEL, Mr. LIPINSKI, Mr. ROTHMAN, Mr. BACA, Mr. BERMAN, Ms. JACKSON-LEE of Texas, Ms. DEGETTE, Mr. DAVIS of Illinois, Mr. STARK, Mr. JOHNSON of Illinois, Mr. COBLE, Mr. LYNCH, Mr. TERRY, Ms. HIRONO, Mr. CONYERS, Mr. HIGGINS, Mrs. MCCARTHY of New York, Mr. SARBANES, Mr. FILNER, Ms. EDDIE BERNICE JOHNSON of Texas, Mr. SCOTT of Virginia, Mr. BLUMENAUER, Mr. MEEKS of New York, Mr. HINOJOSA, Mr. WU, Mr. MELANCON, Ms. HOOLEY, Mr. GRIJALVA, Ms. NORTON, Mr. MCGOVERN, and Mr. DINGELL) introduced the following bill; which was referred to the Committee on Energy and Commerce

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.