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Because of the wide range of functions that a medical device may fulfill, the U.S. Food and Drug Administration (FDA) has implemented a classification system to hold products to standards that are based on the risks posed by their usage. Devices that have the highest chances of causing harm to patients are categorized as Class III devices, so the FDA regulates these strictly. Regardless of which class a medical device is placed in, the product is subject to quality control processes to ensure that it performs its intended purpose and is safe for use.
Since Class III devices involve high levels of risk, the FDA requires the company or individual who is seeking to market the product to apply for premarket approval in addition to the prerequisites all classes of devices must meet. This process involves submitting verifiable scientific data regarding the device’s safety, which is subsequently reviewed by a qualified advisory committee to determine whether it should be allowed on the market.
Medical Device Quality Control
The information that a manufacturer provides about the proper use of a product has to meet FDA safety regulations, just as the product itself does. Marketing a product for use in a way that has not been approved by the FDA could lead to harm, even if the product itself is not defective, and failure to include product risks is a potential safety threat as well. The label must provide all the pertinent information and be designed and produced in a way that facilitates clear understanding. Manuals and electronic messages are included under the umbrella of labeling and are subject to the same regulations.
Arizona Defective Medical Device Attorneys and Product Liability
An Arizona defective medical device attorney notes that health care providers and patients may feel as if they are protected against faulty devices. However, the number of lawsuits filed each year claiming injuries and fatalities may disrupt that sense of security. In fact, at times there are so many similar claims against a company over one product, the federal court system may determine that all of the cases may be consolidated and tried in front of a single district judge. This process, known as multidistrict litigation (MDL), streamlines the litigation process while ensuring that plaintiffs who have suffered similar outcomes receive comparable settlements.
How an Arizona Defective Medical Device Attorney Can Help
Device makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by defective medical devices may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.