FDA Review of Medical Devices: Should Consumers Really Feel Safe?

Abstract

The Food and Drug Administration (FDA), a federal agency within the Department of Health and Human Services (HHS), is responsible for protecting and promoting the public’s health.  The mission of the FDA is to protect the well-being of the public by regulating the safety and effectiveness of drugs and medical devices.  The Center for Devices and Radiological Health (CDRH) manages the FDA medical device approval process.

A medical device is used to diagnose, treat, or prevent disease.  It includes such varied items as hospital gowns, breast implants, and pacemakers.  The United States is the largest producer of medical devices in the world.  In order to sell a medical device in the United States, a submission must first be filed with the FDA, unless the device is otherwise exempted per the regulations.  The FDA review process for a medical device consists of two main routes: premarket approval (PMA) or 510(k) clearance.  While both of these methods allow for FDA review and release of a device for sale in the United States, the 510(k) clearance tends to be considered somewhat of a ‘fast-track’ process.  With no requirement for performance or safety data from patient use, the 510(k) allows for comparison of a new device to a similar, previously cleared device. The 510(k) review is by far the preferred pathway for device manufacturers.

The stakes are high for consumers, healthcare professionals, and device manufacturers in the medical device world. Consumers trust the FDA to assure that devices being used are safe and effective and will not cause harm.  Healthcare professionals seek to treat patients with confidence. Device manufacturers want a quick, low cost approval system that allows them to sell their products in the United States.  The FDA also seeks to provide a process that protects public health and safety, is manageable, and does not stifle innovation.  A regulatory review process that closely encompasses the desires of each group will likely improve public health by allowing for new and innovative products to be made available more quickly to consumers. However, a rush to market may actually overlook deficiencies that exist in devices, allowing harmful products to be used in patients.