Conformity Magazine - December 2008 - (Page 46)

NewsBreaks continued from page 11 EU Commission Issues Correction on Machinery Directive Standards The Commission of the European Union (EU) has issued a correction to its recently released list of standards that can be used to demonstrate conformity with the essential requirements of its directive related to machinery (98/37/EC). The Commission’s correction was published in September in the Official Journal of the European Union, and can be viewed at www. conformity.com/2412. The full list of standards for the Machinery Directive was originally published in August in the Official Journal, and can be viewed at www.conformity.com/2413. 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 guidance document on medical device tracking at www.conformity.com/2414. amended by the 1997 Food and Drug Administration Modernization Act (FDAMA), manufacturers are required to track certain medical devices (mostly implantable devices) in the marketplace, so that the devices can be promptly identified and removed in the event of a product recall. The newly released guidance document on medical device tracking supersedes the version released in August 2008. Our readers can view the complete text of the agency’s guidance document on medical device tracking at www.conformity.com/2416. Guidance Document of Safety of Passive Implants Released The U.S. Food and Drug Administration (FDA) has also released a guidance document covering the safety and compatibility of passive implants used in the magnetic resonance (MR) environment. For device manufacturers preparing premarket approval applications (PMAs), investigational device exemptions (IDEs), and premarket notification (510(k)), this guidance document addresses the testing and labeling of passive implants, and applies to MR devices that serve their function without the supply of electronic power. Active implants or devices that are not implants do not fall within the scope of this guidance document. Our readers can view the complete text of the agency’s guidance document on passive implants at www.conformity.com/2415. FDA Recalls Automated External Defibrillators The U.S. Food and Drug Administration (FDA) has announced the recall of certain automated external defibrillators (AEDs) manufactured by Physio Control, Inc. of Redmond, WA. According to a press release issued by the FDA, the recalled AEDs instruct the responder, by voice prompts, to press the “shock” button on the device. However, the shock button is covered and not visible to the responder, preventing the administration of the required electrical shock to the heart. The recalled devices were distributed from May 2004 through December 2004. The FDA believes that 249 devices are affected by the recall. Our readers can view the FDA’s press release regarding the AED recall at www.conformity.com/2417. FDA Offers Guidance on Marketing Diagnostic Ultrasound Systems The U.S. Food and Drug Administration (FDA) has issued a guidance document for medical device manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. This newly released guidance document supersedes “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,” originally issued in 1997. In that document, manufacturers were required to submit a 510(k) Special Report prior to shipping such devices. Under the new guidance document, manufacturers need not file the Special Report, as long as they maintain acoustic output measurements and labeling records in their design history files. The new guidance document also adds appendices addressing non-OEM replacement transducers and reprocessed “single-use only” transducers, and revises recommended labeling for cleaning and disinfecting transducers. Conformity DeCember 2008 FDA Revises Guidance on Medical Device Tracking Finally, the U.S. Food and Drug Administration (FDA) has released another update to its guidance document on tracking requirements for medical device manufacturers. Under the Safe Medical Devices Act (SMDA) issued in 1990 and Other CPSC Actions in the News In conjunction with the U.S. Consumer Product Safety Commission (CPSC), the following manufacturers, distributors and retailers have issued voluntary recalls for certain consumer electrical http://www.conformity.com/2414 http://www.conformity.com/2416 http://www.conformity.com/2412 http://www.conformity.com/2412 http://www.conformity.com/2413 http://www.conformity.com/2415 http://www.conformity.com/2417

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

Conformity Magazine - December 2008 Contents Editor's Note FCC Warns Regulatory Fee Payers About Potential "Phishing" Commission Prowls the Web to Enforce Its Regulations First DTV Rollout Initiated in Wilmington, NC New Standards List Released for the EU's Directive on the Safety of Toys ESD Association Call for Papers ESDA. JEDEC Announce Standards Development Cooperation Commission Releases Data on Local Telephone Competition The Future of ESD Testing ESD Open Forum Emerging Issues in Standards: China RoHS: One Year and Counting Challenges in Testing: Revisiting 10-Meter and 3-Meter Radiated Emission Measurements Design Fundamentals: Meeting the Shielding Challenges of Injection-Molded Plastics Focus On...Microwave Absorbers Buyer's Guide FDA Recalls Automated External Defibrillators FDA Revises Guidance on Medical Device Tracking Guidance Document Safety of Passive Implants Released FDA Offers Guidance on Marketing Diagnostic Ultrasound Systems EU Commission Issues Correction on Machinery Directive Standards Other CPSC Actions in the News Product Reviews IEC Standards Update UL Standards Update Looking Back: Items from Past Issues of Conformity Advertisers

Conformity Magazine - December 2008

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