Medical Device Safety Act

Bill: 115-hr-2164
Sponsor: full_name: Rep. Fitzpatrick, Brian K. [R-PA-8]
Introduced: 2017-04-26
Policy area: Health
Subjects: Civil actions and liability

Federal preemption

Health technology, devices, supplies

Product safety and quality
Latest action: action_date: 2017-05-05
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2017-04-26
action_desc: Introduced in House
text: <p><b>Medical Device Safety Act</b></p> This bill amends the Federal Food, Drug, and Cosmetic Act to declare that an action for damages or a person's liability under state law is not affected by the federal prohibition on state or local requirements regarding medical devices. This bill is retroactively effective and applies to pending civil actions.

tv_txt: I 115th CONGRESS 1st Session H. R. 2164 IN THE HOUSE OF REPRESENTATIVES April 26, 2017 Mr. Fitzpatrick (for himself, Ms. Slaughter , and Ms. DeLauro ) 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.

1. Short title This Act may be cited as the Medical Device Safety Act . 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.