FDA

Hip Implant Systems Not Adequately Tested

Recently published research reveals that the Food and Drug Administration (FDA) has not done an adequate job at regulating hip replacement systems. As the first trials over Johnson & Johnson’s defective Pinnacle Ultamet hip implant equipment begin across the United States, patients and doctors are left wondering whether these manufacturers were asked to provide evidence […]

FDA Begins Regulating Apps

Everyone with a smartphone or tablet computer has likely run across one of the tens of thousands of health-related apps that can now be downloaded. Some of the apps work by tracking calories, exercise, monitoring blood pressure or blood sugar and others even exist to diagnose health conditions. Despite the seriousness of the apps, there […]

FDA Approval Process Allows Defective Devices to Slip Through the Cracks

A recent study has found a major flaw in the Food and Drug Administration’s process that approves medical devices. At least four dangerously defective medical devices were expedited through FDA’s approval process with minimal testing. The four devices were the DePuy ASR hip implant, transvaginal mesh, heart rings, and defibrillator lead wires. Each of these […]

Consumer Reports Investigates Dangerous Medical Devices and the FDA’s Failure to Protect Consumers from Defective Products

Most medical devices available today are approved by the Federal Drug Administration (“FDA”) through a process known as 510(k) Clearance. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket […]

FDA Scheduled to Hold Meeting on Metal-on-Metal Hip Devices this Summer

The Food and Drug Administration (FDA) has responded to the continued concern of Metal-on-Metal hip implants by announcing a public meeting to discuss the safety and effectiveness of Metal-on-Metal hip implant devices. On June 27 and 28, 2012, the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, which is part of the […]

FDA’s Process for Approving Medical Devices under Review

Medical devices are a crucial part of American Healthcare.  Some medical devices are simple everyday products such as bandages and contact lenses, but other medical devices are complex items such as hip implants, knee implants, pacemakers, or heart-lung machines.  The use of complex medical devices such as hip implants and knee implants are becoming far […]