Latest Center for Devices and Radiological Health Stories

Company must provide transition guide for facilities using Colleague infusion pumps SILVER SPRING, Md., July 13 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO ) (Logo:...

Participants will explore how federal agencies can encourage medical device development SILVER SPRING, Md., June 21 /PRNewswire-USNewswire/ -- Each day, medical devices from renal dialysis machines to implantable defibrillators help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, these devices then undergo a regulatory review process before entering the marketplace. It then takes even more time for them to be adopted into clinical...

SILVER SPRING, Md., May 21 /PRNewswire-USNewswire/ -- Do you have questions about indoor tanning? Did you know that the Food and Drug Administration (FDA) regulates tanning beds? (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) During a 30-minute webinar, experts from FDA will explain what ultraviolet (UV) radiation is and what risks are associated with it. They will also describe ways to reduce the risks posed by UV radiation from tanning beds. An opportunity to ask questions...

Users should seek alternatives, if possible SILVER SPRING, Md., April 27 /PRNewswire-USNewswire/ -- About 280,000 external defibrillators used worldwide in health care facilities, public places, or in the home may malfunction during attempts to rescue people in sudden cardiac arrest, the U.S. Food and Drug Administration warned today. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO ) Sudden cardiac arrest is a condition in which the heart suddenly and unexpectedly stops...

Goal is improved discussion and flow of information SILVER SPRING, Md., April 26 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that it will change the way its expert panels review and discuss data and information during public hearings on medical devices under review for premarket approval, effective May 1, 2010. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) The changes were prompted by an increasing number of medical device advisory panel...

Agency calls for improvements in device design SILVER SPRING, Md., April 23 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced a new initiative to address safety problems associated with external infusion pumps, which are devices that deliver fluids, including nutrients and medications, into a patient's body in a controlled manner. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) As part of its initiative, FDA is moving to establish additional...

Agency's Home Use Initiative to provide guidance, other measures to help caregivers, patients SILVER SPRING, Md., April 20 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced a new initiative to ensure that caregivers and patients safely use complex medical devices in the home. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) Hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices, and ventilators are among...

Site contains new information on Center for Devices and Radiological Health decisions SILVER SPRING, Md., April 19 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration launched the Center for Devices and Radiological Health (CDRH) Transparency Web site today as part of the agency's transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for...

New Rule Applies Requirements in 2007 FDA Amendments Act SILVER SPRING, Md., March 31 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration announced today that it will begin implementing a requirement that device manufacturers provide readily available information in certain premarket applications on pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use. (Logo:...

Esteem approved to treat sensorineural hearing loss SILVER SPRING, Md., March 17 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced the approval of the Esteem - an implanted hearing system used to treat moderate to severe sensorineural hearing loss, a type of permanent hearing loss. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) Sensorineural hearing loss is usually caused by genetic factors or damage to the inner ear resulting from noise, viral...