Title: Laws
Course: BTEC-1300-301-302-303-F21 > Section: Regulations and Medical Devices

A law is a system of rules that a particular country or community recognizes as regulating the actions of its members. Such conduct may be enforced by the imposition of penalties.

In the United states, laws begin as legislation enacted by the US Congress. A bill is introduced by one house of Congress and is considered in committee where public hearings may be held. The bill is then amended as necessary and reintroduced into committee for debate and vote.

Once approved, it becomes an act and goes through a similar process in the other house of Congress.

The act is then submitted to the president. If the president signs the bill, it becomes a law.

The FD&C is a law that dictates the scope of the FDA’s authority

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.