Text of the Medical Device Safety Act of 2009

This bill was introduced on March 5, 2009, in a previous session of Congress, but was not enacted. The text of the bill below is as of Mar 5, 2009 (Introduced).

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Source: GPO



1st Session

H. R. 1346


March 5, 2009

(for himself, Mr. Waxman, Mrs. Capps, Mr. Stupak, Mr. Bishop of Georgia, Mr. Grijalva, Mr. Hinchey, Mr. Doyle, Mr. Higgins, Mr. Olver, Ms. Schakowsky, Mr. Braley of Iowa, Mr. Dingell, Mr. Weiner, Mr. Sarbanes, Ms. Sutton, Mr. Wexler, Mr. Nadler of New York, Mr. Baca, Mr. Hinojosa, Mr. Gene Green of Texas, Mr. Terry, Mr. Kucinich, Mr. Markey of Massachusetts, Ms. Zoe Lofgren of California, Mr. Lipinski, Mr. Wu, Ms. DeGette, Ms. Hirono, Mr. Delahunt, Mr. Scott of Virginia, Ms. Wasserman Schultz, Mr. Blumenauer, Mr. Lincoln Diaz-Balart of Florida, Mr. Brady of Pennsylvania, Mr. Connolly of Virginia, Mr. Meeks of New York, Mr. Conyers, Mr. Johnson of Illinois, Mr. Rothman of New Jersey, Ms. Castor of Florida, Ms. Norton, Mr. Lynch, Mr. Berman, Mr. Boswell, Mr. Schiff, Ms. DeLauro, Mr. Loebsack, Mr. Stark, Mr. Filner, Mr. Rush, Mrs. McCarthy of New York, Mrs. Christensen, Mr. McNerney, Ms. Baldwin, Mr. Butterfield, Ms. Slaughter, Ms. Matsui, Ms. Eddie Bernice Johnson of Texas, Ms. Jackson-Lee of Texas, Mr. Hastings of Florida, Mr. Al Green of Texas, Mr. Welch, Mr. Davis of Alabama, Mr. Johnson of Georgia, and Mr. Hodes) 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 2009.


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.