Index of Questionable Devices

In the United States, medical devices are regulated primarily by the Food and Drug Administration. Federal law require that all devices be safe and effective for their intended use and that new devices have premarket clearance. The current classification system considers (a) the extent to which use of the device involves matters of life or death or serious injury and (b) whether the device is entirely new or is similar to a previously approved device. Simple devices, like bandages and tongue depressors do not require special approval, but the vast majority of devices used for diagnosis and treatment do require approval. Approved devices are listed in the FDA's 510(k) database, which can be searched online. It is sometimes useful to check because some marketers claim that their devices are FDA-approved when they are not.

The devices listed on this page are either inherently bogus or are approved for one use but improperly used for other purposes. A few have gained FDA approval based on "substantially similarity to previously approved devices," even though they are actually intended to be used for unapproved purposes. For example, some bogus devices have been approved as "biofeedback" instruments even though their actual intended use is to diagnose and/or treat disease.

General Information

Devices Promoted with False and/or Misleading Claims

General Information on Other Web Sites

This article was revised on December 27, 2004.

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