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.
Last edited by Fransus; 22nd January 2014 at 02:46 AM.