Conformity Magazine - June 2008 - (Page 76)

NewsBreaks continued from page 11 The Commission found Horizon liable for changing the preferred carriers of 125 consumers without proper authorization. Further, Horizon was charged with including in its written Letter of Authorization (LOA) an inducement for the subscriber to switch carriers (two free roundtrip airline ticket certificates), a practice that is specifically prohibited under FCC rules. Our readers can view the complete text of the Commission’s Notice at www.conformity.com/1811. 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on its Product Review Process The U.S. Food and Drug Administration (FDA) has released an updated version of its draft guidance document on the agency’s program for the expedited review of medical devices submitted for premarket approval. The updated guidance document, which supersedes the prior version released on November 26, 2003, is intended to help medical device manufacturers better understand the procedures to be followed to achieve an efficient expedited review process. Specifically, the updated guidance document no longer includes information on additional conditions for expedited pre-market applications, since these conditions have been eliminated. As we’ve previously reported (see Conformity, May 2008), the FDA has also recently released an updated version of its draft guidance document on the agency’s new interactive product review process, including the premarket review process for medical devices. Guidance documents are intended to provide manufacturers with the agency’s current thinking on specific topics. 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 updated guidance document on the expedited review of premarket submission for devices at www.conformity.com/1813. equipment, also known as the Energy Star program. The issuance of the new EU regulations follows an agreement reached in late 2006 between the EU Council and the U.S. Environmental Protection Agency (EPA) to continue their joint participation in the Energy Star program, and to adopt revised regulations (see Conformity, March 2007). The EPA’s Version 4 of the regulations became effective in July 2007. Our readers can view the complete text of the EU’s revised Energy Star regulations at www.conformity.com/ 1814. FCC Levies $2.6 Million Fine for Junk Faxes The Federal Communications Commission (FCC) has issued a Forfeiture Order for nearly $2.6 million against a Texas-based company for willful and repeated violations of its rules against the sending of unsolicited fax advertisement. The Forfeiture Order cites The Hot Lead LLC, based in Addison, TX, for delivering at least 417 junk faxes to at least 149 consumers. The company also repeatedly failed to respond to Commission communications, beginning in May 2006, when the FCC issued an initial Citation against Hot Lead, followed by two separate Notices of Apparent Liability for Forfeiture, issued in August and December 2007 (see Conformity, November 2007). Violations of the FCC’s regulations regarding junk faxes typically result in proposed monetary fines of up to $11,000 per violation. Our readers can view the complete text of the Commissions’ Forfeiture Order against Hot Lead at www.conformity.com/1812. EU Repeals Directive on Veterinary Electro-Medical Equipment Acting on the advice of the Commission of the European Union (EU), the EU Parliament and Council have repealed the EU’s directive, 84/539/EEC, relating to electro-medical equipment used in veterinary medicine. An announcement published in the March 19th issue of the Official Journal of the European Union notes that “the method of conformity assessment provided for by Council Directive 84/539/EEC is no longer necessary for the purposes of the internal market and trade with third countries,” and that “the functioning of the internal market and the protection of users and animals can be better ensured by other Community legislation.” Our readers can view the complete text of the EU Parliament’s action repealing 84/539/EEC at www.conformity.com/ 1815 EU Issues Updated Energy Star Regulations The Parliament and the Council of the European Union (EU) have issued a revised version of the EU’s energyefficiency labeling program for office 76 Conformity JUnE 2008 http://www.conformity.com/1811 http://www.conformity.com/1814 http://www.conformity.com/1814 http://www.conformity.com/1813 http://www.conformity.com/1815 http://www.conformity.com/1815 http://www.conformity.com/1812

Table of Contents Feed for the Digital Edition of Conformity - June 2008

Conformity - June 2008 Contents Editor's Note 700 MHz Auction Raises a Record $20 Billion FCC Modifies PCS and AWS Power Limit Rules for Broadband Wireless Commission Designates Spectrum Test Bed FCC Releases Report on Wireless Competition Commission Proposes $5 Million Fine for Slamming Using EDX for Non-Destructive Detection of Lead in Consumer Products ESD Open Forum Challenges in Testing - Improving Election Security and Accuracy Part 1 Challenges in Testing - Human Body Model: The Hidden Challenges High-Speed Signal Integrity Considerations for ESD Components Focus On...EMC Components Buyer's Guide FCC Levies $2.6 Million Fine for Junk Faxes FDA Updates Guidance on its Product Review Process EU Issues Updated Energy Star Regulations EU Repeals Directive on Veterinary Electro-Medical Equipment New Product Announcements Updated Standards List for the EU's PPE Directive CPSC Announces New Effort to Keep Out Hazardous Products CPSC Actions in the News IEC Standards Update UL Standards Update Product Reviews Telcordia Standards Update From Our "You Can't Make This Stuff Up" Department Looking Back: Items from Past Issues of Conformity Advertisers

Conformity - June 2008

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