Powell Law’s attorneys maintain a special vigilance for products, especially medical devices, that may be dangerous to consumers. In 2019, defective medical product recalls, including those for artificial hip implants, are much too common. Any product manufacturer, distributor, or otherwise responsible party may be liable for any injuries caused by a defective medical product that […]
A recall is the process of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Medical device recalls are initiated one of two ways: In most cases, a manufacturer, distributor, or otherwise responsible party voluntarily recalls a medical device without any direction from the FDA. When […]
Many people, young and old, have used a medical device to improve their health and well-being. As one might expect, there has been an acceleration in the development of new medical devices in the last twenty-five years. Along with basic clinical and biomedical research, bioengineering research has substantially contributed to the knowledge base underlying the […]
In hoping to ensure that new medical devices reflect modern safety and effectiveness features, the FDA is revising its process for approving medical devices. In modernizing the approval process, the FDA wants to compel companies to base products on devices that are not older than 10 years. For many years, the Food and Drug Administration’s […]