FDA News Digest November 12, 2002 _______________________________________________________________
FDA Approves Rapid HIV Test Kit FDA has approved the OraQuick Rapid HIV-1 Antibody Test, which detects HIV antibodies with 99.6 percent accuracy in as little as 20 minutes using less than a drop of blood. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00852.html _______________________________________________________________ Permanent Heart Assist Pump Approved for Those Ineligible for Transplants FDA has approved HeartMate, a heart assist pump to be implanted permanently in people with severe end-stage congestive heart failure who are not eligible for heart transplants. The device assists weakly beating hearts by taking over the work of the heart's main pumping chamber, the left ventricle. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00851.html ______________________________________________________________ Implanted Device Approved for Permanent Female Sterilization FDA has approved the Essure System, a metallic implant that is placed in the fallopian tubes of women who wish to be permanently sterilized. Unlike currently available surgical sterilization procedures, placement of the device does not require an incision or general anesthesia. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01168.html _______________________________________________________________ FDA Website Offers Background on Medical Device User Fees The Medical Device User Fee and Modernization Act of 2002 gave FDA important new responsibilities, including imposing fees for premarket review of new devices, allowing inspections by third parties, and implementing new requirements for reprocessed single-use devices. A new FDA website explains the law and how FDA will implement it. http://www.fda.gov/cdrh/mdufma/index.html _______________________________________________________________ Food Company Agrees to Withdraw Remaining Gel Candies New Choice Food Inc., a distributor of conjac gel candies, has agreed to an FDA-supervised destruction of 13,000 cases of the candies. This is the latest in a series of actions FDA has taken to protect the public against the candies, which have been linked to choking deaths in children. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00850.html _______________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be November 18. To leave this list at any time, send an e-mail to [EMAIL PROTECTED] In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
