Medical devices include a broad range of products from simple tongue depressors to sophisticated programmable pacemakers with micro-chip technology. Medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. The Food and Drug Administration (FDA) regulates medical device defined as "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." 

This definition provides distinction between a medical device and other FDA regulated products such as drugs. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. Human drugs are regulated by FDA's Center for Drug Evaluation and Research (CDER). Biological products which include blood and blood products, and blood banking equipment are regulated by FDA's Center for Biologics Evaluation and Research (CBER). 

Medical devices vary widely in their complexity and their degree of risk or benefits. There are three regulatory classes based on the level of control necessary to assure safety and effectiveness of the device. Class I - General Controls Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Class I devices are subject to "General Controls" as are Class II and Class III devices.


General controls include companies which are required to register under 21 CFR Part 807.20, such as manufacturers, distributors, repackages and relabelers. Foreign establishments are not required, but are encouraged, to register their facilities with FDA. Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. Special controls may include special labeling requirements, guidance documents, mandatory performance standards and post market surveillance. Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Devices classified into Class III are usually those which support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. The Act contains provisions for changing the classification of a device.

It is always wise to discuss with your doctor your specific care and treatment. Learn about the drugs and medical devices the doctor intends to use. Make sure your doctor is fully familiar with the risk and benefits employed by drugs and devices used in your treatment. If your doctor is unsure, see if you have any other options. If you feel uncomfortable with the doctor, it may be wise to get a second medical opinion and additional information. It is your right as a patient to be fully informed.

In addition to the regulatory safeguard, you may have important legal rights if you improperly suffer adverse consequences because of a medical device If you believe that you might have suffered preventable adverse consequences because of a medical advice, then you ask why. The following are a few important legal, factual and evidentiary issues that should be considered when evaluating a medical device claim.

• What medical device was used and what were the adverse consequences?

• What was the classification of the medical device?

• Was the product properly designed?

• Was the product properly tested?

• Did contract test laboratories fail to perform proper testing?

• Did the product testing conform to valid scientific principles and testing?

• Was the product properly packaged?

• Did the product have proper warnings?

• Were the conditions of use of the product accurately and clearly specified?

• Did the actual product meet design specifications?

• Was the devices correctly installed, checked and serviced?

• Did The Food and Drug Administration (FDA) monitor any problems?

• Is problem data available?

• Have the designers and manufacturers complied with all regulatory requirements?

• Did the manufacturer audit and correct deficiencies?

• Is the device or samples thereof available for testing and inspection?

• How was the product distributed?

• Who participated in the stream of commerce in bring the product to market?

• Did the manufacturer make any misrepresentations regarding the product?

• Did the manufacturer know of problems with the product and fail to take corrective action?

• Was a component of the medical device faulty?

• Did contract test laboratories fail to perform proper testing?

• Did any other entity process, condition, renovate, repackage, restore, or did any other act to a finished device that changes the finished device's performance or safety specifications or intended use? 

If you, a friend, or loved one are the victim of a defective medical device, you should take immediate steps to protect their interest. Do not compromise your rights by making statements to the press, insurance investigators, potential defendants, their representatives, or by signing any documents. After obtain needed medical attention, call us immediately. We are here to help. At Larry King, P.C., we recognize the unique issues pertaining to product claims. You can call us at (757) 595-8100 seven days a week, 24 hours a day, everyday of the year. We also offer a free legal-infoline service, and you can now contact us on this web site by using the following Personal Injury Contact form. We are committed to doing the extra things it takes to help our clients.