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来自 University of Florida 的课程

TECH MeD: Transdisciplinary Education for Critical Hacks of Medical Devices

2 个评分

University of Florida

TECH MeD: Transdisciplinary Education for Critical Hacks of Medical Devices

2 个评分

This course seeks to create an informed public, aware of the technical, medical, legal, and ethical issues associated with implantable medical devices. The course features conversations with experts from a variety of relevant fields to discuss the present and future technological, ethical, legal, and social challenges associated with implantable medical devices. DISCLAIMER: This course is intended for educational purposes only. None of the information provided in this course constitutes medical or legal advice. If you have medical or legal questions, contact your physician or attorney.

从本节课中

Legal Issues

与讲师见面

Lauren Solberg
Assistant Professor
University of Florida, Department of Community Health & Family Medicine
Michael Bachmann
Associate Professor
Texas Christian University, Department of Criminal Justice
Adam Shniderman
Assistant Professor
Texas Christian University, Department of Criminal Justice (Former)
Molly Weinburgh
William L. & Betty F. Adams Chair of Education
Texas Christian University, Andrews Institute of Mathematics & Science Education
Brittany Bachmann

Texas Christian University

Preemption refers to a part of the US Constitution

that says that federal law is the supreme law of the land.

So that basically means that when federal law and state laws are in conflict,

federal law wins, federal law trumps.

So in the context of devices,

there's a provision in a federal law,

in the Federal Drug and Cosmetic Act,

that talks about how states cannot have

additional or different requirements

from federal law with respect to the safety and effectiveness of certain devices.

So preemption could be either expressed or implied.

So if it's expressed there's something in a federal statute that Congress has passed,

and the president has signed,

and it's become federal statutory law or something in one of those laws

that expressly explicitly says that state law is preempted,

is trumped by federal law.

There are a number of different ways that one might

argue that state law is impliedly preempted by federal law.

The implied preemption arguments being that there is nothing

that is explicitly written in a federal statute about preemption,

but nevertheless you can conclude that

Congress intended to display state law through some other means.

In the device context we're talking about expressed preemption, the first kind,

because the Federal Food Drug and Cosmetic Act has this provision

that says that states and other subdivisions of counties, cities,

whomever, cannot impose additional or different requirements on devices;

requirements that are additional or differ from

federal requirements and relate to the safety and effectiveness of certain devices.

And in a case called Riegel v. Medtronic,

the Supreme Court said that this provision really

applies only to devices approved through the pre-market approval process.

So through the PMA process.

So it's for a subset of devices that go through the PMA process.

And in those cases,

and the Supreme Court in Riegel interpreted

the provision of the Federal Food Drug and Cosmetic Act to preempt state tort law.

So even state laws that are not statutory,

even these lawsuits between private parties

can be preempted under this provision of the Federal Food Drug and Cosmetic.

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