Conformity Magazine - April 2008 - (Page 11)

NewsBreaks TCPA. This compares with 15,753 total complaints during the April-June 2006 period, with 12,433 involving TCPA issues. In the area of inquiries, the Bureau also received 6296 inquiries in connection with wireline telecommunications, including 4124 inquiries dealing with TCPA issues, during the period from April through June March 2007. This compares with 35,324 total inquiries during the second quarter of calendar year 2006, of which 23,030 were related to TCPA issues. Our readers can view the complete text of the Commission’s Quarterly Reports at www.conformity.com/1611. devices left in patients following procedures. As required under FDA regulations, nearly 1000 adverse events related to unretrieved device fragments (UDFs) are reported each year to the FDA’s Center for Devices and Radiological Health (CDRH). The consequences include local tissue reaction, infection, perforation and obstruction of blood vessels, and death. Among other recommendations, the FDA’s notification advises medical professionals to inspect medical devices immediately prior to use for any evidence of defects that might increase the likelihood of fragmentation during a medical procedure, as well as immediately after the device is removed from the patient for any signs of breakage or fragmentation. Our readers can view the complete text of the FDA’s notification at www.conformity.com/1613. FDA Offers Guidance on Waivers for In-Vitro Diagnostic Devices The U.S. Food and Drug Administration (FDA) has released a guidance document for those manufacturers seeking a waiver certificate for certain in-vitro diagnostic devices and tests. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the FDA can grant waivers to certain in-vitro diagnostics that are “simple” and which pose “an insignificant risk of an erroneous result.” The agency’s new guidance document describes recommendations for device manufacturers seeking such “waiver status” for their devices. Guidance documents are intended to provide manufacturers with the agency’s current thinking on specific topics. continued on page 78 New Standards List Released For The EU’s Low Voltage Directive 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 related to electrical equipment designed for use within certain voltage limits (2006/95/EC). The list of standards for the directive was published in January 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/1612. (Note that the list runs 78 pages.) Testing � � � Consulting � Engineering � Training EMC COMPLIANCE TESTING FCC Part 15 & 18 CE (Emissions, Immunity & Radio testing) VCCI (Japan) BSMI (Taiwan CNS Standards) Australia/New Zealand (AS/NZS) Korea (KN standards) TELECOMMUNICATIONS TERMINAL EQUIPMENT � � � � � � � � FCC Part 68/ACTA Industry Canada Bellcore Europe CSA Testing TUV Testing UL Testing CE (LVD) PRODUCT SAFETY TESTING � � � � MILITARY AND AVIONICS � � FAA (RTCA DO-160) MIL-STD 461/462 MEDICAL Telecommunications Certification Body (TCB) European Conformity Assessment Body for 2004/108/EC FDA Issues Notification on Unretrieved Device Fragments The U.S. Food and Drug Administration (FDA) has issued a public health notification for healthcare practitioners regarding fragments from medical � � � FDA CE EN 60601-1-2 JIS T 0601-1-2 NARTE Certified Engineers and Test Technicians Consulting Available Over 25 years of EMC Experience Accredited Test Facilities 4 Locations with 10 OATS & 5 semi-anechoic chambers in Southern California Tel: (714) 579-0500 www.celectronics.com April 2008 Conformity 11 http://www.conformity.com/1611 http://www.conformity.com/1613 http://www.conformity.com/1612 http://www.celectronics.com http://www.celectronics.com

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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