Conformity Magazine - April 2008 - (Page 78)

NewsBreaks continued from page 11 However, guidance documents are not legally binding on the FDA, and are not a substitute for existing FDA regulations. Our readers can view the complete text of the agency’s guidance document on in-vitro diagnostic devices at www.conformity.com/1614. notification (510(k)) submissions since, according to the FDA, premarket inspection is not ordinarily conducted for this type of submission. Guidance documents are intended to provide manufacturers with the agency’s current thinking on specific topics, and are not a substitute for existing FDA regulations. Our readers can view the complete text of the agency’s guidance document on PMA applications at www.conformity.com/1615. A New U.S. Standard for Workstation and Computer Design A U.S. standards developer accredited by the American National Standards Institute (ANSI) has published a new standard addressing the design of computer workstations and equipment. The Human Factors and Ergonomics Society (HFES) has issued ANSI/HFES 100-2007, Human Factors Engineering of Computer Workstations, covering a multiplicity of ergonomic design issues, including lighting, seating, monitor displays, and keyboard and mouse placement. An earlier version of the new standard, ANSI/HFS 100-1988, was administratively withdrawn in 1998. Readers can view the complete text of an ANSI article on the new standard at www.conformity.com/1616. Premarket Approval Application Guidance Issued by FDA The U.S. Food and Drug Administration (FDA) has also issued a guidance document intended to provide manufacturers with additional information on the inspection of manufacturing facilities associated with the review of certain premarket approval (PMA) applications. The guidance document details the sequence of events involved in a PMA review, a review of the administrative process and projected timeframes involved in each step, and how the inspection of the manufacturing facility fits into the overall approval process. The guidance document does not address issues related to premarket New Jersey Enacts Electronic Waste Recycling Regulations New Jersey Governor Jon S. Corzine has signed into law a bill that will mandate the collection and recycling of used computers and other electronic products. The new law, the Electronic Waste Recycling Act, becomes effective on January 1, 2009, and bans the disposal of certain electronic devices and components as part of the solid waste stream. Retailers will be required to post information from the state’s Department of Environmental Protection, informing consumers how to recycle the electronic devices covered under the law, and the location of e-waste recycling centers. Electronics producers will be required to pay a $5000 annual state registration fee. In addition, those manufacturers that conduct their own e-waste recycling programs must submit annual reports on their efforts, along with documentation verifying the collection and recycling of their electronic devices. New Jersey is the eighth state in the United States to enact laws covering the control and recycling of e-waste, joining California, Connecticut, Washington, Maryland, Maine, Minnesota and Oregon. Might the CPSC Hold Retailers Accountable for Safe Products? According to a recent Wall Street Journal report, the U.S. Consumer Product Safety Commission (CPSC) may focus additional attention on retailers in its efforts to ensure consumer access to safe products. Speaking at the National Press Club in Washington earlier this year, Nancy Nord, the acting chairman of the CPSC, warned that pending product safety legislation before Congress may require retailers to make sure that the products they sell are tested and certified for safety. Answering a reporter’s question following her prepared remarks, Nord noted that retailers that sell products have “the ultimate responsibility at the end of the day to make sure that their 78 Conformity April 2008 http://www.conformity.com/1614 http://www.conformity.com/1615 http://www.conformity.com/1616 http://www.ieee-pses.org http://www.nepss.org http://www.nepss.org

Table of Contents Feed for the Digital Edition of Conformity Magazine - April 2008

Conformity Magazine - April 2008 NewsBreaks Editor’s Note Mandatory Analog Cellular Service Ends FCC Releases Quarterly Reports on Consumer Inquiries and Complaints New Standards List Released for The EU’s Low Voltage Directive FDA Issues Notification on Unretrieved Device Fragments FDA Offers Guidance on Waivers for In-Vitro Diagnostic Devices ESD Open Forum Emerging Issues in Standards Challenges in Testing Design Fundamentals Focus on... New Products Product Reviews Premarket Approval Application Guidance Issued by FDA New Jersey Enacts Electronic Waste Recycling Regulations A New U.S. Standard for Workstation and Computer Design Might the CPSC Hold Retailers Accountable for Safe Products? CPSC Loses “Sole Toy Tester” CPSC Actions in the News IEC Standards Update UL Standards Update Telcordia Standards Update From Our “You Can’t Make This Stuff Up” Department Looking Back: Items from Past Issues of Conformity Advertisers

Conformity Magazine - April 2008

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