yea such e“A ‘\ eed J carn A vl a0 ant 5 aNsn “ay we Aan all ott FD:YA, ee“= ed ike ad OF SAFETY Facts from the US.ve = Drug Administration FDA’s Center For Devices (NAPSA)—If you are looking for unbiased information about medical devices such as contact lenses, breast implants, laboratory tests, or Lasik eye surgery, you might want to check out the Internet site of the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH)at www.fda.gov /cdrh. Since passage of the Medical Device Amendments of 1976, CDRH has been responsible for approving or clearing medical devices marketed in the United States. During the past 25 years CDRH has accumulated a wealth of information about the medical devices that it regulates. Believing that its responsibility is to educate and inform as well as regulate, CDRH is making information available not only to scientists and the medical device industry but to patients and consumers. Under the leadership of David W. Feigal, Jr., M.D., Director, CDRH, the Center began an ambitious organizational planning process through the year 2005 to evaluate its critical programs for protecting the health of the public using medical devices. Recognizing that medical devices often last for years, a concept called Total Product Life Cycle (or TPLC for short) was born. TPLC follows the life of a medical device from its conception through its development and use, and finally its “death.” Dr. Feigal has refocused the Center’s programs to consider Total Product Life Cycle \ / 7 Center for Devices and Radiological Health @ TPLC when evaluating new medical device applications and resolving problems with medical devices already in use. The Center’s Internet site contains information on all aspects of the regulatory process. It includes an extensive consumer site and searchable databases about new medical device approvals and information about specific devices such as hearing aids. Its mammography site contains technical and consumer information and links to the FDA and Health and Human Services (HHS) homepages. These links broaden the information available about other healthcare products such as drugs, vaccines, and food supplements. If you don’t have a computer, many libraries provide access to the Internet through their computers. Community and senior centers sometimes have computers for public use as well.
