As you learn about regulations it is easy to lose perspective and get bogged down in rules. Dealing with government regulation is often boring and frustrating! However, there are good reasons for the requirements of medical device manufacturing. The regulations are the result of past tragedies such as the sulfanilamide and thalidomide incidents, as well as many other incidents of the last century.

What follows is a quote from a woman describing the death of her child to Franklin Delano Roosevelt following the sulfanilamide tragedy in 1938

> “The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and for and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight.“

The regulations and laws are an effort to prevent tragedies like this from happening again.

Learning Objectives:

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