Conformity Magazine - March 2008 - (Page 11)

NewsBreaks Our readers can view the complete text of the FDA’s report at www.conformity.com/1512. FDA Offers Guidance on its Product Review Process The U.S. Food and Drug Administration (FDA) has released a draft guidance document on the agency’s new interactive product review process, including the premarket review process for medical devices. The interactive product review process is a result of aggressive new performance goals established by the U.S. Congress in its reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA) in October 2007. According to the Guidance document, the FDA believes that a formalized interactive review process will “encourage and facilitate communication between FDA staff and industry during the review of specific medical device premarket notification submissions,” and lead to a “timely completion of the review based on accurate and complete information.” The Guidance document describes the roles and responsibilities of the agency and applicants in the interactive review process for 501(k)s, original premarket approval applications (PMAs), PMA supplements, original biologics license applications (BLAs), and BLA supplements. 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 latest Guidance document at www.conformity.com/1513. FDA Publishes Updates to List of Recognized Standards The U.S. Food and Drug Administration (FDA) has issued a Notice of changes to the list of standards the agency recognizes for use in pre-market reviews for medical devices. The list, Modifications to the List of Recognized Standards, Recognition List Number: 19, is intended to assist manufacturers who choose to demonstrate compliance with requirements for medical devices by conforming with consensus standards, and is regularly updated by the agency. The Notice, which was published in December in the Federal Register, identifies nearly 40 separate standards that are being withdrawn from the FDA’s list of consensus standards, as well as 20 new entries and standards that have not previously been recognized by the agency. Our readers can view the complete text of the FDA’s Notice as published in the Federal Register at www.conformity.com/1514. FDA Warns of Patient Risk from Electric Dental Handpieces The U.S. Food and Drug Administration (FDA) has issued a press release warning dental health professionals of potential risks to patients from poorly maintained electric-powered handpieces. According to the FDA, some patients have been severely burned when a poorly maintained electric dental handpiece is used during dental continued on page 5 � 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 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-anehoic chambers in Southern California Tel: (714) 579-0500 www.celectronics.com marCh 2008 Conformity 11 http://www.conformity.com/1512 http://www.conformity.com/1514 http://www.celectronics.com http://www.conformity.com/1513 http://www.celectronics.com

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

Conformity Magazine - March 2008 NewsBreaks Editor's Note Adelstein Renominated to the FCC Industry Canada Publishes FAQs On RF Fields FDA Gives Its Scientific Capabilities Poor Marks FDA Offers Guidance On its Product Review Process FDA Publishes Updates to List of Recognized Standards FDA Warns of Patient Risk From Electric Dental Handpieces Complying with the EMC Directive, Second Edition ESD Open Forum Emerging Issues in Standards - Korean "RoHS": Not Like RoHS at All The iNARTE Informer Challenges in Testing - Field-Induced Charged Device Model: What Really Happens Design Fundamentals - EMI Shielding Technologies for Consumer Electronics Equipment Focus On...Compliance Software Buyer's Guide Additional Standards Published for the EU's ATEX Directive Additional Standards for the EU's Medical Devices Directive Also Published China to Require Bar Codes to Enhance Product Safety CPSC Releases 2007 Self-Assessment CPSC Actions in 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 Magazine - March 2008

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