Lecture 3 _Authorities Having Jurisdiction_2011

Lecture 3 _Authorities Having Jurisdiction_2011 - U S...

Info iconThis preview shows pages 1–11. Sign up to view the full content.

View Full Document Right Arrow Icon
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
Background image of page 1

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
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!
Background image of page 2
Center for Devices and Radiological Health 3 Product Development for Medical Applications Authorities Having Jurisdiction
Background image of page 3

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
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.
Background image of page 4
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
Background image of page 5

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
Center for Devices and Radiological Health 6 Product Development for Medical Applications
Background image of page 6
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
Background image of page 7

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
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".
Background image of page 8
Center for Devices and Radiological Health 9 Product Development for Medical Applications
Background image of page 9

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
Center for Devices and Radiological Health 10 Product Development for Medical Applications Private Law Bodies Also well constituted. Don't
Background image of page 10
Image of page 11
This is the end of the preview. Sign up to access the rest of the document.

This note was uploaded on 07/08/2011 for the course BM 501 taught by Professor Kop during the Spring '11 term at Bloomsburg.

Page1 / 80

Lecture 3 _Authorities Having Jurisdiction_2011 - U S...

This preview shows document pages 1 - 11. Sign up to view the full document.

View Full Document Right Arrow Icon
Ask a homework question - tutors are online