Conformity - November 2008 - (Page 54) NewsBreaks continued from page 11 mode when talking. In both cases, the cell phone is positioned away from the head and body, and exposure to radiation drops off dramatically when the phone is held more than 3-4 inches away from the user. One other way to reduce exposure to cell phone radiation? Text messaging, since the user typically holds the phone away from their body when texting. FDA Increases Medical Device User Fees for FY 2009 The U.S. Food and Drug Administration (FDA) has announced an increase in the user fees it charges manufacturers for its premarket reviews of a wide variety of medical devices. Of particular interest to our readers is the revised fee structure for 510(k) applications for medical devices. As of October 1st, the FDA now charges a standard fee of $3693 for each 510(k) application submitted for its review. This represents an 8.5% increase over the $3404 fee charged in fiscal year 2008, but the new fee is still considerably less than the $4158 charged by the agency in fiscal year 2007. (The original user fee in 2003 was just $2187.) For those applicants whose total annual revenues fall below established thresholds, thereby qualifying as a “small business,” the fee for fiscal year 2009 is $1847, also an 8.5% increase over last year’s fee of $1702, but well below the $3326 charged by the agency in fiscal year 2007. In addition, the annual “establishment registration” fee applicable to all manufacturers who are required to register under section 510 of the FD&C Act, has been increased from $1706 in fiscal year 2008 to $1851 this year. Our readers can view the complete text of the FDA’s Notice regarding its new medical device user fees as published in the Federal Register at www.conformity.com/2314. demonstrate conformity with the essential requirements of its directive relating to electrical equipment designed for use within certain voltage limits (2006/95/EC). The list of standards for the directive was published in August in the Official Journal of the European Union, and replaces all previously published standards lists. Our readers can view the complete list at www.conformity.com/2315. (Note that the list runs approximately 90 pages.) Wireless Medical Systems May Pose Patient Risk A Dutch study has determined that many medical equipment malfunctions in hospital settings may be linked to wireless control systems used in the same environment. The study, which was recently published in the Journal of the American Medical Association (JAMA), was based on 123 tests conducted on equipment found in an intensive-care unit at a hospital in Amsterdam, the Netherlands. In the tests, researchers placed microprocessors similar to those found in wireless medical devices within a foot of various types of critical care medical equipment, including respirators, external pacemakers and dialysis machines. The result? According to the study, electromagnetic “glitches” occurred in almost 30% of the tests, and nearly 20% of the malfunctions were serious enough that they would have harmed patients (the tests were conducted on equipment not connected to patients). The study’s authors warn hospitals to test wireless items before using them in close proximity to critical care systems. New Standards List Released For the EU’s Machinery Directive The Commission of the European Union (EU) has issued an updated list of standards that can be used to demonstrate conformity with the essential requirements of its directive related to machinery (98/37/EC). The list of standards for the directive was published in August in the Official Journal of the European Union, and replaces all previously published standards lists for the directive. Our readers can view the complete list at www.conformity.com/2316. (Note that the list runs more than 50 pages.) Updated Standards List For the EU’s ATEX Directive Released The Commission of the European Union (EU) has published an updated list of standards that can be used to demonstrate conformity with the essential requirements of its Directive 94/9/EC concerning equipment and protective systems intended for use in potentially explosive atmospheres (also known as the ATEX Directive). The list of standards was published in August in the Official Journal, and replaces all previously published standards lists for the directive. Our readers can view the complete list of standards at www.conformity.com/2317. Updated Standards List For the “New” Low Voltage Directive The Commission of the European Union (EU) has published an updated list of standards that can be used to 5 Conformity november 2008 http://www.conformity.com/2315 http://www.conformity.com/2316 http://www.conformity.com/2314 http://www.conformity.com/2317
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