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What We Do

The FDA's Center for Devices and Radiological Health (CDRH) assures 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 CDRH website provides information about specific medical devices for patients and consumers, medical device manufacturers and health care professionals. The CDRH Consumer Information page gives links to FDA information about buying and using medical devices. The Devices@FDA Web site lets you search for detailed information about specific medical devices, including diagnostic tests. Use this website to:

• Find out if devices are approved by FDA
• Get phone numbers and addresses of medical device companies
• Read and print patient information and instructions for use
• Learn about changes to devices since they were approved

In addition, the links below give general information about medical devices used for specific medical conditions, and links to FDA Web pages for these devices and/or their associated conditions.

Medical Devices

Cardiovascular Conditions

Cardiovascular disease (CVD) is not one single disease or condition. It is a group of different disorders that affect your heart and blood vessels. You are born with some types of cardiovascular diseases, and you develop others during your lifetime. The links below give general information about medical devices used for cardiovascular conditions.

• Automated External Defibrillator (AED)
• Cardiac Ablation Catheter
• Cardiac Angioplasty Device
• Cardiac Pacemaker (Implanted)
• Implantable Cardioverter Defibrillator (ICD)
• Prosthetic Heart Valve
• Stent
• Ventricular Assist Device (VAD)

For more information, visit FDA’s Heart Health Online Web site at http://www.fda.gov/hearthealth/.

Cochlear Implants

Cochlear implants are electronic hearing devices implanted into people with severe to profound hearing loss to produce useful hearing sensations. Visit CDRH’s Cochlear Implants Web site for more information http://www.fda.gov/cdrh/cochlear/index.html.

Diabetes

FDA regulates the medical products used to treat diabetes, including glucose meters, insulin pumps, diabetes medicines, and insulin. The following links provide general information about glucose meters and other diabetes management tests, lancing devices and sharps disposal.

• Glucose Meters and Diabetes Management Tests : Glucose meters help people with diabetes check their blood sugar at home, school, work, and play. Other blood and urine tests reveal trends in diabetes management and help identify diabetes complications. http://www.fda.gov/diabetes/glucose.html

• Lancing Devices and Sharps Disposal: Lancets and other lancing devices are sharp blades or needles used to obtain blood samples for glucose testing. Manufacturers often provide lancing devices as part of glucose monitoring kits. After you use a lancing device, you must dispose of it in a safe container to prevent needle sticks. http://www.fda.gov/diabetes/lancing.html.

For more information, visit FDA’s Diabetes Information Web site at http://www.fda.gov/diabetes/.  

LASIK Eye Surgery

LASIK is a surgical procedure using an excimer laser intended to reduce a person's dependency on glasses or contact lenses. FDA’s Lasik Eye Surgery Web site provides information to the public about LASIK surgery http://www.fda.gov/cdrh/lasik/. 

Phakic Intraocular Lenses

Phakic intraocular lenses are new devices used to correct nearsightedness. These thin lenses are implanted permanently into the eye to help reduce the need for glasses or contact lenses. FDA’s Phakic Intraocular Lenses Web site contains information help you learn more about phakic lenses http://www.fda.gov/cdrh/phakic/.

Radiation-Emitting Products

Computed Tomography (CT)

Computed Tomography (CT), also known as “computerized axial tomography" (CAT), uses X-rays to produce images representing "slices" of the body - like the slices of a loaf of bread. Each image slice corresponds to a wafer-thin section which can be viewed to reveal body structures in great detail.

CT is recognized as an invaluable medical tool for the diagnosis of disease, trauma, or abnormality in patients with signs or symptoms of disease. It's also used for planning, guiding, and monitoring therapy. What's new is that CT is being marketed as a preventive or proactive health care measure to healthy individuals who have no symptoms of disease. But whole body scanning using CT provides uncertain benefits with the potential for some risk due to the level of radiation. To read more about this, visit FDA’s Whole Body Scanning website at: http://www.fda.gov/cdrh/ct/.

Mammography

A mammogram is a safe, low-dose x-ray picture of the breast. It is currently the most effective method of detecting breast cancer in its earliest, most treatable stages. FDA regulates mammography services under the Mammography Quality Standards Act (MQSA), which established minimum national quality standards for mammography facilities to ensure safe, reliable, and accurate mammography. Read more about FDA’s Mammography program at http://www.fda.gov/cdrh/mammography/index.html.

Updated December 29, 2005