Conformity Magazine- May 2008 - (Page 65) NewsBreaks FDA Updates Guidance on its Product Review Process The U.S. Food and Drug Administration (FDA) has released an updated version of its draft guidance document on the agency’s new interactive product review process, including the premarket review process for medical devices. The FDA’s interactive product review process is a result of aggressive new performance goals established by the U.S. Congress in its reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA) in October 2007. As we’ve previously reported (see Conformity, March 2008), the Guidance document describes the roles and responsibilities of the agency and applicants in the interactive review process for 501(k)s, original premarket approval applications (PMAs), PMA supplements, original biologics license applications (BLAs), and BLA supplements. The update Guidance document was issued on February 28, 2008, and supersedes the earlier release dated December 28, 2007. Our readers can view the complete text of the agency’s updated guidance document on the interactive review process for medical devices at www.conformity.com/1722. has recalled about 2100 gas clothes dryers. The company says that a short circuit in the dryer’s wiring poses a shock hazard to consumers with ungrounded dryers. GE has not received any reports of incidents or injuries related to the recalled dryers, but has initiated the recall to prevent future incidents and injuries. The recalled dryers were sold through retail stores and authorized builder distributors nationwide from September 2006 through October 2007 for about $440. Remote Controlled Helicopter Toys: Soft Air USA, Inc. of Grapevine, TX is recalling about 30,000 remote-controlled helicopter toys manufactured in China. Soft Air says that the rechargeable battery contained inside the helicopter can catch fire during charging, igniting the helicopter and nearby combustible A Practical Learning Experience for Professionals Bring Your Questions. We’ll Bring the Experts. Learn practical knowledge you can use on the job right now! Let our experts share their knowledge and know-how in this informative half-day event. You’ll also take home a set of bound notes to use as a handy reference guide. The event is free and there is no cost or obligation, but space is limited, so register early! Get more information at: www.techtoursite.com CPSC Actions in the News In conjunction with the U.S. Consumer Product Safety Commission (CPSC), the following manufacturers have issued voluntary recalls for certain consumer electrical and electronic products. Here are the details: Gas Dryers: The Consumer and Industrial division of General Electric 2008 Tour Schedule Dallas, TX – April 8 Melbourne, FL – May 20 Westford, MA – April 24 San Diego, CA – June 26 Dearborn, MI – Sept 17 Drawing for an iPod Nano at the end of every event ETS-LINDGREN ROHDE & SCHWARZ SILENT CONFORMITY MAGAZINE mAy 2008 Conformity 5 Sponsored by: http://www.techtoursite.com http://www.conformity.com/1722 http://www.techtoursite.com
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