May 2008

Who knew dental floss was a medical device regulated by the U.S. Food and Drug Administration (FDA)? What about contact lenses, tongue depressors, or bedpans? How about pacemakers? You guessed it, they all are!

One might naturally think of a product like a defibrillator as a medical device, but in our business, we find many companies unsure if its products are, in fact, medical devices.

The following is a helpful guide to get you through the medical device maze. First is a description of what medical devices are, and helpful hints so that you may identify if your product is regulated as a medical device. Second is a brief overview of FDA’s regulation of medical devices.

What is a Medical Device?

The technical definition of a medical device, found in section 201(h) of the Federal Food Drug & Cosmetic Act (FD&C Act) is:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it’s […]