More than 20,000 firms worldwide produce over 80,000 brands and models of medical devices for the U.S. market, ranging from contact lenses and blood sugar monitors to implanted hip joints and heart valves. The FDA's Center for Devices and Radiological Health (CDRH) makes sure that new medical devices are safe and effective before they are marketed. Many of these devices are the first of a kind, such as a robotic arm that can operate a variety of surgical tools with tremendous precision. Other high-tech devices are designed to prevent, diagnose or treat cancer, heart disease, impaired vision and hearing, and other health problems. The center also monitors devices throughout the product life cycle, including a nationwide postmarket surveillance system. And it assures that radiation-emitting products, such as microwave ovens, TV sets, cell phones, and laser products meet radiation safety standards.
The size of the CDRH workload is reflected in its performance statistics for 2001: 3,507 new products received marketing clearance, including 29 devices representing breakthrough technologies; 1,098 ongoing device trials were monitored; and 216 new clinical studies to test the safety and effectiveness of experimental devices in humans were approved.
Although its workload is rapidly increasing, CDRH has streamlined its processes and reduced the average review time for novel and high-risk medical devices, which offer the greatest potential health benefits to patients. Between 1995 and 2000, approval times for these products declined from 26 months to 12 months.
In the near future, CDRH will be challenged to resolve complex issues connected with emerging technological and demographic developments, including:
For more information, please call CDRH at 301-827-7975.
CDRH's approvals in 2001 included numerous state-of-the-art medical devices, such as: