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Medical Devices

The FDA approves medical devices for sale, but it does not guarantee that a particular product is safe or risk-free. Medical device defects are often categorized as either design defects (which are part of the basic design of the product, including the marketing and warnings), or manufacturing defects (which occur as an unintended consequence of the manufacturing process). Some medical devices are categorized by type, such as those that treat heart problems or gastric disorders, leading to different standards of care and liability. In other cases, some products may be approved based on their intended use in general healthcare without any specific labeling requirements for individual doctors. If a doctor uses one of these products for something different than what it was actually approved for by the FDA, it could create additional liability.