Only choose FDA approved medical devices to ensure your safety

Medical devices can be anything from bandages to pacemakers, with thousands of products in between. But with all medical devices, consumers share one concern—they want them to be safe. Since medical devices are meant to help us live healthier lives, it is imperative that they are healthy themselves. Luckily, consumers don’t have to worry much about the safety of medical products in the United States, especially if they get a medical device from a legitimate retailer or hospital. That’s because the Food and Drug Administration, or FDA, takes great care to regulate these products and ensure their safety.

Whenever you use a more complicated medical product at home or under the supervision of a doctor, you should take the time to make sure the product is an fda medical device. An fda medical device has undergone strict scrutiny; it has been proven to be safe and effective. Under fda guidelines, no new medical device may be marketed without the Administration’s approval. Therefore, if you find a product in a store or at a hospital, it is most likely safe.

Three kinds of fda medical devices

The FDA classes medical devices into three categories, and it regulates each class in a different manner. Class I devices are products that cause minimal potential harm to users. This class is made up primarily of devices that are simple in design, like bandages, tongue depressors, and plastic gloves. Almost half of all medical devices on the market fall into this category. The majority of products in Class I are so simple and harmless that they don’t even need special fda approval.

Class II fda medical devices includes products that are more likely to cause harm in humans if they were to fail or be used improperly. Most medical devices found in hospitals and doctors’ offices are considered to be Class II products. These items do need to be approved by the fda before they can be marketed and sold in the United States. Some examples of Class II fda medical devices include heart monitors, power wheelchairs, and automatic blood pressure cuffs.

The third class of fda medical devices contains the products with the most potential for endangering life if they were to be used improperly. These Class III devices are often used inside the body; only about 10 percent of all medical supplies fit into this category. Examples of Class III fda medical devices include pacemakers and most anesthetics.

Steps you can take for your safety

The approval phase for a medical device varies depending on the class it is placed in. It can take a long time—and proof of several trials—for a Class III item to be approved. In general, the products that have the most potential to be harmful—those in Classes II and III—will only be available through large retailers and doctors. You probably won’t have to worry about fda approval if you gain access to the medical devices through these routes, but it can’t hurt to double check. Go to the FDA’s web site at; here, the Administration maintains a list of approved products, recalled products, and devices to avoid.

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