There is a popular series of books in the U.S. that all start with: “The Complete Idiot’s Guide to…” I counted 765 books advertised with subjects including “The Internet”, “The Kama Sutra” and “The Bible”.  Who would buy a book with such an insulting title?  

The answer is: any of us who, with a smile, can admit that we are overwhelmed with acronyms, jargon and convoluted language, and yearn for simplicity.  

In this series of columns, I hope to discuss basic FDA requirements for medical devices.    Medisourceasia has a broad audience with different levels of understanding of FDA requirements. So, please forgive me when I discuss material you already know. On the other hand, there may be subjects that you do not understand and possibly some even no one really understands.  Laws and regulations are written by a complex process involving lawyers, politicians, consumers, physicians and scientists.  I learned that sometimes logic does not always seem to play a role.   When I first started my career, I challenged a lawyer at a committee meeting.  I sheepishly raised my hand and said: “But, that contradicts what you just said a moment ago”.  He roared like a lion and said: “Lawyers are not bound by logic and reasoning-that’s for scientists!”  I told that story when I tried to explain U.S. law at meetings with Ministry of Health officials in Beijing, Bangkok and Singapore.  Then, I explained how water is regulated in the U.S. as a cosmetic ingredient if it you claim it is used to clean your skin, but is regulated as a pharmaceutical if you claim it removes wrinkles.  In the United States, a product is regulated by what it claims on its labeling rather than just its composition.

A question for you:  Can water also be regulated as a medical device?  Let’s look at the definition:  A device 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:

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

• 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

• 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 primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Look at the underlined section. The answer is that water is not regulated as a medical device if its primary intended use is achieved through chemical action within or on the body.  Water could, I suppose, be an in vitro reagent, according to this definition, if it claimed use, for example, to diagnose a disease by being used on a blood sample. “In vitro” is Latin for, “within a glass”, i.e. in a test-tube.

If I discuss material for which you still have questions, write to me at yourFDAconsultant@medisourceasia.com and I will try to answer you.  This column is for you and I welcome your suggestions on how to improve it.  

Dr. Norman F. Estrin

June 22, 2002