Medical Device Regulation: US or EU

Food, Drug and Cosmetic Act
In the States, medical devices are regulated by the Food, Drug and Cosmetic Act. Then called the Food and Drug Act, it was the first piece of legislation to result from investigative journalism, namely a novel titled “The Jungle” by Upton Sinclair. Sinclair described the filthy conditions of pre-WWI Chicago stockyards and the contamination of our food supply. You can still buy the book, a heart-wrenching, stomach-punching period piece, for $5.95. Sinclair published The Jungle in 1906, and the Food and Drug Act was passed in 1923. In 1933, as part of the ‘New Deal’, legislation was introduced to expand the Act to cover medical devices; the expansion passed in 1938.

Adulteration and Misbranding
The Food and Drug Act set forth two simple concepts that still govern medical devices today—adulteration and misbranding. Adulteration speaks to the issue of filth, contamination, or toxins being present in or on a medical device. For example, some devices use water during the manufacturing process. The water must be pyrogen free or the finished device will probably be contaminated with pyrogenic material. Pyrogens cause an intense fever spike when they get into the body—an unwanted medical occurrence for any device.

Misbranding speaks to the issue of making false or misleading statements. For example, if I say the device can be used to reduce an HIV viral load, but it not cleared for this indication, it is misbranded. If I say it is sharp enough for a surgical cut and it isn’t, it is misbranded.


If I say the knife is sterile, and it isn’t, it is both adulterated and misbranded. CDG Workshops & e-Conferences: Introduction to Medical Device Regulation: US.

Leave a Comment

This site uses Akismet to reduce spam. Learn how your comment data is processed.