The FDA

The Food and Drug Administration (FDA) is the preeminent medical regulatory system in the world.  The FDA is charged with ensuring the safety and effectiveness of medical devices in the United States and regulates more than 1700 types of devices, 500,000 medical device models, and 23,000 manufacturers.    They receive several thousand new and supplemental device applications annually and they are mandated by Congress to complete their pre-market evaluations in a timely fashion. 

This pre-approval product assessment may include computer simulations, engineering analyses, non-clinical laboratory testing, animal testing, and human clinical studies.  Although many products undergo testing in humans before FDA approval, it is not a requirement.  Unanswered questions regarding device safety and performance often remain at the time of FDA approval and the ability of the FDA to identify and predict which products will perform safely after approval is limited.  This creates the potential for a large number of patients to be rapidly exposed to a newly approved product in the absence of long-term follow-up data.

Therefore, it is not surprising that the FDA annually receives reports of more than 200,000 device-related injuries and malfunctions, and more than 2000 device-related deaths.  While post-marketing studies are occasionally used to monitor device performance and safety, patients sometimes fail to receive critical information about their medical device's performance.  As a result, they may be unnecessarily exposed to potentially faulty products.  At times, potentially flawed products may be marketed unbeknownst to the consumer while the manufacturer submits revised marketing applications and awaits FDA approval of the amended product design and manufacturing plan.

Although robust, FDA product evaluation and approval does not guarantee a product’s safety.  Additional consumer safeguards are needed to minimize adverse health consequences and improve the safety of medical devices for the millions of patients who enjoy their benefits.

Click Here to go to the FDA website.