The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Common Quality Assurance Processes and Tools > Definitions, Acronyms, Abbreviations and Interpretations
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Legal and Regulatory Requirements - Differences


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links



Courtesy Quick Links

Links that Cove visitors will find useful in your quest for knowledge:


ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Atul's
Quality Forum Online

Howard's
International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Related LinkedIn Groups

ISO 9001 for Small Businesses

ISO 9001:2015 Revision Discussions

Information Security Community

Medical Devices Group

Quality and Regulatory Network

FDA (Food and Drugs)

AS91XX Series - Tips and Advice


Related Topic Tags
differences (general), legal requirements, regulations and regulatory requirements, regulatory requirements
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 1st February 2006, 10:57 AM
HDR

 
 
Total Posts: 8
Question Legal and Regulatory Requirements - Differences

Is there a difference between legal and regulatory requirements?

If yes, can someone provide me a clear definition of each?


THANK YOU ...

HR

Sponsored Links
  Post Number #2  
Old 1st February 2006, 11:00 AM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,156
Have a look at this thread: Please define statutory and legal requirements
Sponsored Links

  Post Number #3  
Old 1st February 2006, 02:27 PM
km214's Avatar
km214

 
 
Total Posts: 42
Look! Legal and Regulatory

Law is defined as: Main Entry: 1law
Pronunciation: 'lo
Function: noun
Etymology: Middle English, from Old English lagu, of Scandinavian origin; akin to Old Norse log law; akin to Old English licgan to lie -- more at LIE
1 a (1) : a binding custom or practice of a community : a rule of conduct or action prescribed or formally recognized as binding or enforced by a controlling authority (2) : the whole body of such customs, practices, or rules

Regulation is defined as:Main Entry: 1reg·u·la·tion
Pronunciation: "re-gy&-'lA-sh&n, "re-g&-
Function: noun
1 : the act of regulating : the state of being regulated
2 a : an authoritative rule dealing with details or procedure <safety regulations> b : a rule or order issued by an executive authority or regulatory agency of a government and having the force of law
3 a : the process of redistributing material (as in an embryo) to restore a damaged or lost part independent of new tissue growth b : the mechanism by which an early embryo maintains normal development
synonym see LAW

Therefore, they are synonyms of each other and usually used interchangably..
Thank You
  Post Number #4  
Old 1st February 2006, 04:47 PM
BSMITH

 
 
Total Posts: 99
Laws vs Reglations

Laws are usually more general or less specific than regulations. An example in the U.S. is the Clean Water Act (a law); the regulations that implement the Clean Water Act are those in Title 40 of the CFR (Code of Federal Regulations). In some cases individual Federal agencies have their own regulations that dictate how they implement the Act. State laws and regulations pretty much work the same way; in some cases the State law implements a Federal law; in other cases there is no comparable Federal law.

A more detailed discussion can be found at: http://www.epa.gov/epahome/lawintro.htm
Thank You to BSMITH for your informative Post and/or Attachment!
  Post Number #5  
Old 1st February 2006, 06:40 PM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 5,793
Good discussion, and I liked BSmith's answer very much.
  Post Number #6  
Old 22nd January 2014, 02:25 AM
Fransus

 
 
Total Posts: 1
Re: Is there a difference between legal and regulatory requirements?

Many people are confused about the difference between laws and regulations. Laws and regulations are rules. But, they differ in how they came into being. The difference between laws and regulations is:

Laws are enacted by a governing body, in the U.S. an elected governing body called Congress. Similar elected bodies enact laws in other countries. Enacted laws are enforceable in court. The Food, Drug and Cosmetic Act (FD&CA)is an example of an enacted law.

Regulations are laws made by agencies. Agency-made laws are called regulations. As with enacted laws, agency-made laws, regulations, are enforceable in court. Regulations made by the FDA are examples of agency-made law.

Enacted laws and agency-made laws, which are called regulations, are similar in that they state legal requirements and are enforceable in court. Regulations are limited in this way:

An agency can create regulations only if an enacted law authorizes it to do so. A law authorizing an agency to make regulations is called a “Rules Enabling Statute.” (A statute is an enacted law that has been given a number and published in an official book of statutes, or “codified.”) An agency can create regulations only to implement or enforce the enacted law.

A section of the enacted law, FD&CA, authorized the creation of the FDA, and authorized the agency to make regulations to carry out the FD&CA. FDA cannot in its own discretion broaden, or narrow, the FD&CA.

In contrast to regulations, FDA guidelines are not laws, and are not in themselves enforceable in court. Similarly, standards, which are collective works setting forth specifications and methods for achieving them, by organizations having interest and expertise in the subject area, are not in themselves, legally enforceable. Sometimes, however, a standard is “incorporated by reference” into an enacted law or regulation thereby making that standard a part of the law.

A common mistake in the medical device world is where people fail to recognize the distinction between regulations, which state legally enforceable requirements, and other types of authority, such as guidelines and standards, or internal procedures, which are useful for establishing norms and procedures, but do not state the legal requirement.

I am a regulatory and compliance lawyer and a scientist. Lawyers are the professional group with the training and qualifications to interpret rules, like enacted laws and regulations, and evaluate how well an organization’s procedures and practices meet the legal requirements.

In contrast, scientists, physicians, engineers, and other technicians have the special skills to design and execute protocols and procedures. Some technical people have the skills to design procedures and test plans to demonstrate that the technology performs, or is likely to perform, as intended and designed. While different from legal/regulatory interpretation, the skills to develop and execute a test plan to demonstrate that a device does, and will continue to, do what you intended it to do, are critical to medical device development.

Regards, Fransus

Last edited by Fransus; 22nd January 2014 at 02:46 AM. Reason: formatting
Thank You to Fransus for your informative Post and/or Attachment!
  Post Number #7  
Old 22nd January 2014, 02:43 AM
Randy's Avatar
Randy

 
 
Total Posts: 8,370
Re: Is there a difference between legal and regulatory requirements?

Very good answer Fransus, but if you'll check you're in a discussion that pretty much ended 8 years ago.

For the sake of this discussion within the context of ISO 9001 the answer is pretty much NO, there is no difference unless you'd like to consider contract requirements as "legal".
  Post Number #8  
Old 22nd January 2014, 08:16 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,894
Re: Legal and Regulatory Requirements - Differences

Welcome to the Cove, Fransus and a great start

Your clarification on the subject is great !
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Common Quality Assurance Processes and Tools > Definitions, Acronyms, Abbreviations and Interpretations

Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
7.4.1.1 Statutory & Regulatory Conformity: Legal Requirements of which Country? morteza TS 16949 - International Automotive Quality Systems Standard 4 5th May 2012 10:21 AM
TGA Guidelines on Australian & EU Medical Device Regulatory Requirements Differences bio_subbu Other Medical Device Regulations World-Wide 5 29th December 2010 02:01 AM
Update Service for Legal & Regulatory Requirements quality1 Environmental Related Standards 3 11th January 2009 07:50 PM
Commitment and Compliance with Legal & Regulatory Requirements SaintStan Environmental Related Standards 2 13th September 2007 10:59 AM
Legal Requirements - How Legal Requirements apply to environmental aspects? ISO 14001 ugurkavi Environmental Related Standards 7 9th May 2006 07:18 AM



The time now is 02:46 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 


NOTE: This forum uses "Cookies" -- The Elsmar Cove is *Copyright Free*.
A Peachfarm LLC Internet Property