FDA News Digest
October 25, 2004
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IN THIS WEEK'S ISSUE
-- FDA Action Plan Aims to Boost Safety of Fresh Produce
-- New Device Uses Ultrasound, MRI to Treat Uterine Fibroids
-- FDA Offers Patient Information on Recently Approved Devices
-- Recalls/Market Withdrawals
-- Recent Speeches
-- Public Meetings
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FDA Action Plan Aims to Boost Safety of Fresh Produce
Emphasizing the importance of fresh fruits and vegetables to healthy diets, FDA has developed an action plan to minimize foodborne illness associated with eating fresh produce. The plan covers the produce supply chain "from the farm to the table" -- major points where contamination can occur.
Press release: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01318.html
Action Plan text: http://www.cfsan.fda.gov/%7Edms/prodpla2.html
New Device Uses Ultrasound, MRI to Treat Uterine Fibroids
FDA has approved the ExAblate 2000 System, a medical device that targets and destroys uterine fibroids, a non-cancerous condition affecting up to 40 percent of women aged 35 and older. The system uses magnetic resonance imaging to guide an ultrasound beam that uses high-energy sound waves to destroy the fibroid tissue.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01319.html
FDA Offers Patient Information on Recently Approved Devices
FDA's Center for Devices and Radiological Health has created consumer information Web pages for three medical devices recently approved for treating various conditions. The pages, linked on the following list, briefly describe the devices, and explain what they are intended to do and how they should and should not be used.
-- Cardiac Resynchronization Therapy Defibrillators (to help coordinate heart rhythms and improve blood pumping in certain heart failure patients)
http://www.fda.gov/cdrh/MDA/DOCS/p010012s026.html
-- Intacs Prescription Inserts for Keratoconus (to reduce nearsightedness and irregular astigmatism caused by keratoconus)
http://www.fda.gov/cdrh/MDA/DOCS/h040002.html
-- Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
http://www.fda.gov/cdrh/mda/docs/p010062.html
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RECALLS/MARKET WITHDRAWALS
The following products are being recalled for the reasons shown. Go to the linked page for more information.
Appledore Atlantic Smoked Salmon; 4-oz. and 8-oz. packages (possible Listeria contamination)
http://www.fda.gov/oc/po/firmrecalls/appledore10_04.html
Amy's Kitchen Whole Meal Enchilada with Spanish Rice and Beans; 4,800 being recalled (some may contain undeclared cheese)
http://www.fda.gov/oc/po/firmrecalls/AmysKitchen10_04.html
Kirin Combi Cookies; 15-pkg. cases (undeclared peanuts)
http://www.fda.gov/oc/po/firmrecalls/kenneth10_04.html
Lotte/Margaret Korean Crackers; 1.1-lb. box (undeclared egg)
http://www.fda.gov/oc/po/firmrecalls/wang10_04.html
Creamline Chocolate Cow milk; with "sell by" date of 10/20 (incomplete pasteurization)
http://www.fda.gov/oc/po/firmrecalls/springhouse10_04.html
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 60 days, go to
http://www.fda.gov/opacom/7alerts.html
To access the RSS feed of FDA recalls information, go to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml
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RECENT SPEECHES
FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Cleveland Clinic Foundation's 2004 Medical Innovation Summit (Oct. 20)
http://www.fda.gov/oc/speeches/2004/cleveland1020.html
To view an archive of past speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm
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PUBLIC MEETINGS
Oct. 28 -- Egg Safety: Proposed Rule for Preventing Salmonella enteritidis in Shell Eggs (College Park, Md.)
http://www.cfsan.fda.gov/~dms/egg1004.html
Nov. 8 -- Stimulating Innovation in Medical Technology; Washington, D.C.
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-23064.htm
Nov. 18 -- Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002; Gaithersburg, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-21676.htm
For a list of FDA meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html
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