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The Food and Drug
Administration (FDA) has exerted regulatory control over
medical devices since 1976 when the Medical Device Amendments
to the Food, Drug and Cosmetic Act were signed into law. These
amendments set up a system where devices were divided into
three classes and seven categories. The classes are based on
the amount of risk involved in the use of that product while
the categories are defined as pre-market, post-market,
substantially equivalent, implant, custom, investigational,
and transitional. The amount of review that a device must
undergo is determined by its class and category.
The focus of most litigation
has been in the Class III, substantially equivalent category.
A Class III medical device is defined as a device which
demonstrates a potentially unreasonable risk of harm.
"Substantially equivalent" means that a device was
in use or existence prior to 1976 and is substantially
equivalent to the device to be marketed today. The rationale
is that if it has a history of safe use then there is less
need for stringent testing for the new device. Unfortunately,
companies often try to push through "substantially
equivalent" devices which have real differences to their
predecessor, all in order to avoid the rigors of the approval
process. Of course not all litigation has been in this class
and category.
Over the last several decades,
litigation involving medical devices has included such
products as Medtronic’s Pacemaker Polyurethane-Insulated
leads, TMJ Jaw Implants, breast implants and most recently
Sulzer Hip Implants. Medical Devices FAQsHow is a medical device claim determined?
Do I need a lawyer if I believe I may have a drug or medical device claim?
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