When it comes to medical devices, patients in Houston may feel secure if they learn that the device is cleared by the U.S. Food and Drug Administration. However, this security can be misleading. This is because there is a significant difference between a product being FDA cleared and FDA approved.
The FDA regulates prescription drugs, over-the-counter drugs, biologics, medical devices and surgical implants, among other products. If a product is FDA approved, this means that the FDA has determined that the benefits of the product are greater than any known risks that may accompany the use of the product in the way it was intended. For FDA approval, the manufacturer of the product must provide the agency with a premarket approval application as well as the results of the clinical tests of the product. FDA approval is generally required to sell products in the nation that have a significant benefit but also present the potential for significant risks. Class III medical devices, such as pacemakers, breast implants and replacement heart valves must be FDA approved.
However, Class II and Class I medical devices generally only need to be FDA cleared. This means that the manufacturer of the product can show that it is substantially equivalent to similar products on the market that have already been FDA cleared or approved. FDA cleared products can be sold on store shelves in the U.S.
This becomes problematic when the products a Class II or Class I medical device are compared to are recalled. This means that even a “FDA cleared” medical device can still be defective and could harm consumers. This is why sometimes defective medical device litigation is based on products that were FDA cleared or even FDA approved.
Most of the time when we need a medical device, we assume that if it is on store shelves and is being used by physicians across the nation, it is safe. Unfortunately, that is not always the case. Sometimes a medical device proves to be defective, injuring consumers and necessitating litigation. Those who want more information on defective medical device litigation are encouraged to seek the professional legal guidance they need to make decisions that are in their best interests.