Medical Device Safety Act

I 116TH CONGRESS 1ST SESSION H. R. 2669 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 MAY 10, 2019 Ms. DELAURO (for herself, Ms. SCHAKOWSKY, and Mr. FITZPATRICK) intro- duced 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Medical Device Safety 4 Act’’. 5 VerDate Sep 11 2014 23:09 May 20, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2669.IH H2669 pbinns on DSK79D2C42PROD with BILLS 2 •HR 2669 IH SEC. 2. LIABILITY UNDER STATE AND LOCAL REQUIRE- 1 MENTS RESPECTING DEVICES. 2 (a) AMENDMENT.—Section 521 of the Federal Food, 3 Drug, and Cosmetic Act (21 U.S.C. 360k) is amended by 4 adding at the end the following: 5 ‘‘(c) NO EFFECT ON LIABILITY UNDER STATE 6 LAW.—Nothing in this section shall be construed to mod- 7 ify or otherwise affect any action for damages or the liabil- 8 ity of any person under the law of any State.’’. 9 (b) EFFECTIVE DATE; APPLICABILITY.—The amend- 10 ment made by subsection (a) shall— 11 (1) take effect as if included in the enactment 12 of the Medical Device Amendments of 1976 (Public 13 Law 94–295); and 14 (2) apply to any civil action pending or filed on 15 or after the date of enactment of this Act. 16 Æ VerDate Sep 11 2014 23:09 May 20, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H2669.IH H2669 pbinns on DSK79D2C42PROD with BILLS