Better Health Care with Quality Medical Devices:
FDA on the Cutting Edge of Device Technology
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:
Diagnosis and treatment options related to the human genome project
Radiation safety issues, including those associated with new medical
Breakthrough devices using artificial intelligence, nanotechnology
Special needs of our aging population for prosthetics, cardiac interventions,
and home health care.
For more information, please call CDRH at 301-827-7975.
Advances in Medical Device Technology
CDRH's approvals in 2001 included numerous state-of-the-art medical devices,
the first implanted pacemaker that includes a tiny transmitter that automatically
transmits data on the patient's heart condition to the physician
a vest-like device for patients who cannot have an implanted defibrillator
and are at risk of dying from heart attack; the device senses heart malfunction
and automatically delivers an electrical shock to restore normal heart rhythm
a wristwatch-like device for diabetics that automatically checks the wearer's
glucose level every 20 minutes and sounds an alarm if it is dangerously high
an inflatable device that is surgically placed around the upper stomach
of greatly overweight patients who cannot lose weight by dieting and are at
serious risk for weight-associated serious diseases, such as hypertension;
the device limits their food consumption and creates an earlier feeling of
a swallowable capsule with tiny camera that snaps pictures as it moves
through the small intestine; the device helps detect bleeding and other abnormalities
that are reachable by endoscope.