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