Conformity Magazine- May 2008 - (Page 64) NewsBreaks continued from page 11 Commission Issues Report on Telephone Subscribership The Federal Communications Commission (FCC) has released its most recent report on telephone subscriber levels in the United States. The report, which is based on 2007 statistics from the Census Bureau, provides subscriber penetration statistics by state, income level, race, age, household size and employment status. Among the report’s highlights are the following key findings: • The telephone subscriber penetration rate increased to 95.6% by July 2007, versus a penetration rate of 94.6% a year earlier; • Penetration rates for households with incomes above $100,000 was over 99%, while penetration for households with incomes below $20,000 was at or below 93.2%; • Penetration rates by state range from a high of 98% in Vermont, to a low of 89.8% in Mississippi; • The penetration rate for employed adults was 96.1%; for unemployed adults, the penetration rate was 92.8%. Our readers can view the complete text of the Commission’s Report at www.conformity.com/1715. essential requirements of its Directive 2004/22/EC concerning measuring instruments. The first list of CEN and CENELEC standards was published in the February 1 issue of the Official Journal of the European Union, while a list of an additional 3 CENELEC standards was published in the February 20th issue. Our readers can view the lists of standards for the directive at www.conformity.com/1716, and at www.conformity.com/1717. Finally, the Commission has published an updated list of standards that can be used to demonstrate conformity with the essential requirements of its Directive 98/79/EC, dealing with in vitro diagnostic medical devices. The list of CEN standards was also published in the February 27 issue of the Official Journal, and replaces all previously published standards lists for the directive. The list can be viewed at www.conformity.com/1720. Updated Standards List For The EU’s Medical Devices Directive The Commission of the European Union (EU) has also published an updated list of standards that can be used to demonstrate conformity with the essential requirements of its Directive 93/42/EEC concerning medical devices. The extensive list of CEN standards was published in the February 27 issue of 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/1718. FDA Proposes Reclassification of Medical Device Data Systems The U.S. Food and Drug Administration (FDA) has proposed changes to its regulations that would allow certain computer and software-based medical devices to be introduced to the market without premarket review and approval. The proposed rule, which was published in February in the Federal Register, would reclassify so-called medical device data systems (MDDS) from class III (requiring premarket approval) to class I (general controls), when such devices are indicated for use only by healthcare professionals, and when such devices do not perform irreversible data compression. The FDA says that, under such circumstances, MDDS “present a low risk, and should not be subject to premarket review that have not been classified elsewhere.” Comments on the proposed rule changes are due to the FDA by May 8th. Interested readers can view the complete text of the proposed changes as published in the Federal Register at www.conformity.com/1721. Updated Standards List for EU Directive on Active Implantable, In Vitro Medical Devices The EU Commission has also published an updated list of standards that can be used to demonstrate conformity with the essential requirements of its Directive 90/38/EEC, relating to active implantable medical devices. The list of CEN standards, which was published in the February 27 issue of the Official Journal, replaces all previously published standards lists for the directive, and can be viewed at www.conformity.com/1719. Standards Lists For The EU’s Directive on Measuring Instruments The Commission of the European Union (EU) has published updated lists of standards that can be used to demonstrate conformity with the Conformity mAy 2008 http://www.conformity.com/1716 http://www.conformity.com/1717 http://www.conformity.com/1720 http://www.conformity.com/1718 http://www.conformity.com/1715 http://www.conformity.com/1721 http://www.conformity.com/1719
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