What is a ‘Medical Device’?
A medical device is a product used by patients for medical purposes. This includes diagnosis, therapy or surgery. When used, the effect of the medical device is primarily physical, as opposed to pharmaceutical drugs, which have a chemical effect.
Medical devices include a wide range of products, from the most basic item like a tongue depressor to the complex such as an artificial heart. Each year, hundreds of new and different medical devices, including joint replacement components (knees, elbows, hips, ankles), cosmetic implants (chin, breast, buttocks, calf), and surgical instruments are placed on the market by medical device manufacturers.
The Food & Drug Administration (FDA) is supposed to be responsible for testing and approving each and every medical device for safety and efficacy. However, the truth is that the FDA is unable to carefully test and screen all such devices. In recent years, the approval process for medical devices has been accelerated.
According to the FDA, their mission is based on “… taking a balanced public health approach – to protect and promote public health – by assuring that medical devices on the market are safe and effective while also facilitating innovation.” But, even with the best intentions, there have been several circumstances when the FDA simply approves a new medical device on the basis of its “substantial similarity” to an already existing device.
If you or a loved one has been injured due to exposure to a defective medical device, please contact the defective medical device attorneys at Schlichter Bogard & Denton for a free consultation today.