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

The text of the bill below is as of Jun 26, 2008 (Introduced).

Source: GPO



2d Session

H. R. 6381


June 26, 2008

(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


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


Short title

This Act may be cited as the Medical Device Safety Act of 2008.


Liability under state and local requirements respecting devices



Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360k) is amended by adding at the end the following:


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.



Effective date; applicability

The amendment made by subsection (a) shall—


take effect as if included in the enactment of the Medical Device Amendments of 1976 (Public Law 94–295); and


apply to any civil action pending or filed on or after the date of enactment of this Act.