Conformity Magazine - July 2008 - (Page 10)

NewsBreaks FCC Adopts $6 Million in DTV Enforcement Orders Continuing its strict enforcement of its regulations related to the transition to digital television (DTV) in February 2009, the Federal Communications Commission (FCC) has adopted a string of enforcement orders against television manufacturers, importers and retailers. The 11 separate enforcement orders propose monetary forfeitures totaling more than $6.5 million, and include the following Commission actions: • Seven separate notes of Apparent Liability for Forfeiture for violations of the DTV labeling requirements. Companies named include Sears, Roebuck, K-Mart, Wal-Mart, Circuit City, CompUSA, Best Buy, Target and Fry’s Electronics. • A Forfeiture Order and Further Notice of Apparent Liability for digital tuner rule violations against Syntax-Brillian and Precor. • Two Notices of Liability for violations of the FCC’s V-Chip rules against Polaroid and Proview Technology. Our readers can view the complete text of the Commission’s press release regarding its DTV enforcement efforts at www.conformity.com/1910. Commission Enforcement Bureau Adopts V-Chip Consent Decree In a separate action, the Enforcement Bureau of the Federal Communications Commission (FCC) has adopted consent decrees with seven separate manufacturers involving possible violations of the Commission’s V-Chip requirements. The consent decrees carried with them “voluntary contributions” to the FCC totaling almost $3.5 million. In addition, the consent decrees require the manufacturers to take specific steps to ensure future compliance, including fixing non-compliant televisions already on the market, training employees on FCC rules, and providing periodic reports to the Commission verifying compliance. The seven companies entering into consent decrees with the FCC are LG Electronics, Philips Consumer Electronics, Sanyo, Vizio, Panasonic, Westinghouse Digital Electronics, and Audiovox Our readers can view the complete text of the Commission’s press release regarding its V-Chip consent decrees at www.conformity.com/1911. FDA Seeks $2 Million from Medical Device Manufacturer The U.S. Food and Drug Administration (FDA) says that it will seek a $2.2 million penalty against a California manufacturer of cochlear implants for failing to notify the agency of a change in an outside vendor or supplier, a change the FDA says “may have exposed recipients of the devices to unnecessary health risks.” Cochlear implants are devices that are surgically implanted under the skin behind the ear as a treatment for severe hearing loss. Such devices are categorized by the FDA as Class III devices, the most stringent device category. According to the FDA, the company, Advanced Bionics of Sylmar, CA, allegedly shipped cochlear implants to customers in the United States prior to filing the required supplemental information with the agency, including a notice of changes made to the devices that affected their safety and effectiveness. Specifically, Advanced Bionics is charged with failing to sufficiently evaluate and select a new vendor as the supplier of a critical device component, and failing to adequately validate the continued safety and effectiveness of the implant by testing samples of the DiLBErt: © Scott Adams/Dist. by United feature Syndicate, inc. reprinted with permission. 10 Conformity JULy 2008 http://www.conformity.com/1911 http://www.conformity.com/1910

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

Conformity Magazine - July 2008 Contents Editor's Note FCC Adopts 6 Million Dollars in DTV Enforcement Orders Commission Enforcement Bureau Adopts V-Chip Consent Decree FDA Seeks 2 Million Dollars from Medical Device Manufacturer FDA Answers Questions About CFLs and UV Radiation EPA Issues Energy Star Specs for TV, Video Boxes Canada Unveils Sweeping Product Safety Legislation How the Evolution of CISPR Standards Continues to Shape the Requirements for Anechoic Chambers ESD Open Forum Reach Compliance for Non-EU Article Manufacturers The iNARTE Informer Preamplifier Considerations for Emission Measurement Systems Effective Shielding in Medical Electronics Applications Product News Focus On...Power Components Buyer's Guide Updated Standards List for the EU's ATEX Directive EOS/ESD Symposium Set for September CPSC Actions in the News Researchers Work to Develop Non-Flammable Batteries Safety Link Launches Redesigned, Enhanced Web Site 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 Magazine - July 2008

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