DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 01-5

FDA Web site: www.fda.gov

Revised: February 2002

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 imaging technologies

• Breakthrough devices using

artificial intelligence, nanotechnology and robotics

• Special needs of our aging

population for prosthetics,

cardiac interventions, and home

health care.

For more information, please

call CDRH at 301-443-4690, or

visit the FDA Web site at

www.fda.gov/cdrh.

Advances in Medical Device

Technology

CDRH’s approvals in 2001 included

numerous state-of-the-art medical

devices, such as:

• 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 fullness

• 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.