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What is the Difference Between FDA-Approved and FDA-Cleared Medical Devices?

Philadelphia defective medical device lawyers advocate for victims of FDA approved devices.The types of products that are subject to Food and Drug Administration (FDA) approval are more extensive than one might think. In addition to prescription drugs and foods, the FDA evaluates cosmetics, vaccines, over-the-counter-drugs, infant formula, surgical implants, and medical devices. Although this testing is essential for public health and safety, the system is not fool-proof. Patients that require medical devices will do themselves a favor by considering the differences between the various types of FDA product testing and procedures, since many people have suffered complications from defective products.

Medical Device Classifications

The FDA uses three categories for medical devices: Class I, II, and III. The first two groupings include items that pose less risk because they are non-invasive. Class I devices include bandages, hand-held surgical instruments, and tongue depressors; examples of Class II devices are powered wheelchairs, x-ray machines, and suture materials. Interestingly, the Apple Watch ECG app that records electrocardiograms is classified as Class II. Class III devices are more complex, and subject to more rigorous testing since they are placed inside the body. They can be life-sustaining, but can also pose the risk of significant illness or injury. These devices include replacement heart valves and pacemakers.

FDA Approval

To get approved, Class III devices, vaccines, and medications must be shown to have more benefits than risks for users. Manufacturing companies have to submit premarket approval applications as well as clinical testing results. The FDA generally approves those that show significantly higher benefits than risks. They do not produce or develop the products they review, and they do no actually perform the testing. This is done in clinics and independent labs, and the results are sent to the FDA for review.

FDA Clearance

FDA clearance applies to the lower-risk Class I and II medical devices. For these, the companies must show that the products are equivalent to similar devices on the market legally that have received FDA approval or clearance. They submit premarket notification submissions over to the FDA for product review and clearance. Once this happens, the products can be sold. Even when medical devices and products gain FDA clearance or approval, they are not necessarily safe. Many victims have experienced serious health problems from these devices, and most people are familiar with the class-action lawsuits that have been carried out against manufacturers.

Newer Medical Products

In addition to the Apple Watch ECG app, other companies are selling newer medical tech devices, which have received FDA clearance. In the near future, these tech companies may be marketing Class III, hospital-grade devices, so patients that are aware of the clearance and approval processes will be better able to make informed medical decisions.

Philadelphia Defective Medical Device Lawyers at Brookman, Rosenberg, Brown & Sandler Advocate for Injured Victims of Harmful Devices

If you or someone you love experienced complications from a defective medical device, the Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler can help. For a free consultation, call us at 215-569-4000 or complete an online form. Located in Philadelphia, we serve clients throughout Pennsylvania and New Jersey, including Delaware County, Chester County, and Philadelphia County.