FDA Clears for Marketing First Quick Test For Malaria. The BINOX Now Malaria Test is the first rapid-test for malaria cleared for marketing in the U.S. The Binox test gives results fifteen minutes after a small blood sample is deposited on a dipstick. Additional information is available at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01659.html.
CDRH Releases New Guidance to Industry and Staff: Pharmacogenetic Tests and Genetic Tests for Heritable Markers. The Center for Devices and Radiological Health, on June 26, 2007, issued the final guidance document for pharmacogenetics tests and tests for heritable markers. The guidance document provides a general framework that should be addressed in any genetic test submission, and presents industry and academia a common baseline from which to operate. Additional information is available at http://www.fda.gov/cdrh/oivd/guidance/1549.pdf.
Shelhigh Enters Consent Agreement With FDA. Shelhigh, Inc. has settled it’s dispute with FDA, entering an agreement whereby Shelhigh will halt device production until they bring their production processes into GMP compliance. Shelhigh is a manufacturer of implantable devices such as pediatric heart valves and conduits, dural patches, and arterial grafts. Additional information is available at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01658.html.
MDUFMA Cleared for Floor Debate. On June 21, 2007, the Medical Device User Fee & Modernization Act of 2007 was approved by the House Energy and Commerce Committee for floor debate in the House. This bill is largely similar to previously negotiated proposed bills, with the addition of some post-market safety provisions such as a study of nosocomial infections attributable to both new and reused devices. Additional information is available at www.thegraysheet.com. (paid subscription service).
Cardiac Ultrasound Appropriateness Criteria Released. The American College of Cardiology Foundation and American Society of Echocardiography have identified 44 appropriate indications of use and 11 contraindications for the use of transthoracic and transesophageal echocardiographs. The working group’s conclusions will be published in the July Journal of the American Society of Echocardiography and the July 10 issue of The Journal of the American College of Cardiology. Additional information is available at www.thegraysheet.com. (paid subscription service).
Supreme Court Will Hear Product Liability Case Against Medtronic. The United States Supreme Court has agreed to hear a case against Medtronic that could decide if patients can press product liability claims against firms with products that have undergone FDA’s premarket clearance process. The Court has declined to hear similar cases five times since 2001. Additional information is available at http://www.bloomberg.com/apps/news?pid=washingtonstory&sid=anr1prpkdCf8.