In my last article (See Archives), we reviewed the definition of a medical device.  We now know, for example, that if our product is advertised or labeled with a claim that it is to be used for the diagnosis, cure, treatment, prevention, etc. of a disease or to affect the structure or function of the body, and we want to market it in the U.S., it is regulated by the FDA.  

There are a whole series of laws that give the FDA authority to regulate medical devices.  These include the Federal Food, Drug, and Cosmetic (FFD&C) Act of 1938, The Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, FDA Export Reform and Enhancement Act of 1996 and the Food and Drug Administration Modernization Act of 1997.  The names are not as important as the fact that the provisions in these laws give the FDA the authority to publish regulations.  The FDA usually does this by publishing proposals in the Federal Register for comment and then, after evaluating all the comments, publishes a final regulation in the Federal Register.  The final regulations are, on an annual basis, placed in the Code of Federal Regulations (CFR).  Most medical device regulations can be found in Title 21 CFR Parts 800-1299. This volume may be purchased from the United States Government Printing Office through http://www.access.gpo.gov/su_docs/chklst/chklst.html.

The FDA regulates medical devices through its Center for Devices &Radiological Health (CDRH).   We often overlook the second part of the name.  It means that the FDA also has authority over products that produce electronic product radiation.  Most of these products are not medical devices unless, of course, you make a medical claim for them!  Radiation emitting products have special recording, reporting and labeling regulatory requirements.

(1) The term "electronic product radiation" means:

• (A) any ionizing or non-ionizing electromagnetic or particulate radiation, or

• (B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product;

(2) The term "electronic product" means:

• (A) any manufactured or assembled product which, when in operation,

• (i) contains or acts as part of an electronic circuit and

• (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or

• (B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation.  The term "manufacturer" means any person engaged in the business of manufacturing, assembling, or importing of electronic products.

Radiation-emitting products include such diverse products as television sets, X-ray machines, electron microscopes, tanning machines, radar devices, electromedical equipment, lasers, communications transmitters, vibrators, sound amplification equipment, and  ultrasonic cauterizers. Remember that if you make any medical claims for such products, your product is a medical device also subject to medical device regulations in addition to the provisions for radiation emitting products. 

CDRH has many responsibilities but I can only highlight a few.  The Office of Device Evaluation (ODE) oversees FDA’s medical device approval and clearance programs. The Office of Compliance looks at advertising and promotion issues, schedules inspections and otherwise enforces the medical device laws.  One especially helpful part of the CDRH is the Division of Small Manufacturers, International and Consumer Assistance (DSMICA).  Its job is to provide technical and regulatory help to medical device companies. You can FAX your questions to 1-301-443-8818 or email them to yourFDAconsultant@medisourceasia.com

Dr. Norman F. Estrin

July 19, 2002