Lecture 3 _Authorities Having Jurisdiction_2011

Lecture 3 _Authorities Having Jurisdiction_2011 - U S...

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Center for Devices and Radiological Health U. S. Department of Health and Human Services Product Development for Medical Applications Wednesday April 13, 2011 Authorities Having Jurisdiction [AHJ] Or Swimming with Sharks Brian Fitzgerald 1
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Center for Devices and Radiological Health 2 Product Development for Medical Applications Who am I? Brian Fitzgerald Deputy Division Director, Division of Software and Electronic Engineering, Office of Science and Engineering Laboratories WO62-4218 Silver Spring, MD 20993-0002 [email protected] (301) 796-2579 Assistance is also available from the Division of Small Manufacturers, International and Consumer Assistance, http://www.fda.gov/cdrh/industry/support. You don’t have to be a manufacturer or consumer to avail yourself of their service!
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Center for Devices and Radiological Health 3 Product Development for Medical Applications Authorities Having Jurisdiction
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Center for Devices and Radiological Health 4 Product Development for Medical Applications Constitutional law A brief civics reminder. A constitution is: How sovereign states organize their internal legal regime. or from Wikipedia; A Constitution is a system, often codified in a written document, which establishes the fundamental rules and principles by which an organization is governed. In the case of nation states, this term refers specifically to a national constitution, which defines its nation's fundamental political principles and establishes the power and duties of each government. Most national constitutions also guarantee certain rights to the people Constitution says nothing about biomedical, or even health and safety. But all kinds of constitutionally valid laws create or allow authorities who can mess with you.
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Center for Devices and Radiological Health 5 Product Development for Medical Applications Legal systems sanctioned by the US constitution 50 legal systems in the States of the Union 3 Federal legal systems US UCMJ First nations Hundreds
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Center for Devices and Radiological Health 6 Product Development for Medical Applications
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Center for Devices and Radiological Health 7 Product Development for Medical Applications Public Law Bodies Based in Constitutional law Enforcement powers Police and courts Financed from public purse e.g. Federal e.g. State or Provincial e.g. Municipal and county
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Center for Devices and Radiological Health 8 Product Development for Medical Applications Public Law Bodies Legally constituted. Must apply to everyone! Every person. Made by elected officials. Congress. Parliaments. Council Parish "The term Person includes individual, partnership, corporation and association".
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Center for Devices and Radiological Health 9 Product Development for Medical Applications
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Center for Devices and Radiological Health 10 Product Development for Medical Applications Private Law Bodies Also well constituted.
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