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Mar 2012 ­ July 2012

SoftwareCPR.com Newsletter

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Standards and Regulatory Highlights: The Chinese SFDA prepared a draft document entitled "Explanations on the Basic Requirements of Application for Registration of Medical Device Software" date 4/28/12. This was initially translated to English by JIRA (Japan Industries Association of Radiological Systems) and Shawn Yang of SoftwareCPR® (a native Chinese speaker and US medical device software expert) reviewed the original Chinese and made some corrections and clarifications to the translation. Paid subscribers to softwarecpr.com and Standards Navigator subscribers can download this from our website library with their login. FDA released a new guidance dated July 3, 2012 entitled " Clinical Performance Assessment: Considerations for ComputerAssisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions. Many other new items are listed on the following pages and available on our website. SoftwareCPR® News: Mary Decareau of SoftwareCPR® prepared an EN 62366 Medical devices - Application of usability engineering to medical device checklist for our use and we are making it available to paid subscribers as well in our document library and checklists topic. We can bring courses on Efficient Use of Medical Device Software Standards EN62304 and 8002-1, FDA Software Medical Device Software Validation and Submissions, Assurance/Safety Cases, Risk Management, Validation of Regulated Automation, and other topics tailored to your needs directly to your facility. Our commitment to compliant yet efficient use of Agile Methods continues along with our belief that this can actually lead to safer medical device software when properly done. Brian Pate is a lead expert in this area and is available for consulting and training. Part of our approach, for groups that already have some Agile exposure, is to hold workout sessions to address compliance gaps in Agile fashion expediting process improvements. We continue to expand our risk based code review and static analysis services and have recently added the LDRA tool as part of this service. We now provide a service to help you develop Safety/Assurance Cases including use of your existing risk management documentation to more efficiently generate summaries in the form of assurance cases for premarket submissions as well as code inspection and design review services focused on risk management. We have a premium subscription service called Software STANDARDS NAVIGATOR led by Sherman Eagles. This provides real time insight, guidance, monthly reports, and access to public draft standards as well as some consulting or training time each year. Click TOPICS and then click the Standards Navigator topic to get further information. We continue to be actively involved in standards development including the AAMI TIR on Use of Agile Methods for Medical Device Software, Revision of IEC 62304, a new AAMI/FDA working group on Assurance Cases, Health IT standards and many others. Please be sure to check out our "topic" pages. Try these out by clicking (http://www.softwarecpr.com/topicsframepage.htm). Paid subscribers should log in and then will have access to all educational documents while others will have only limited access. Remember that additional documents are available by browsing or searching the library.

20 Berkshire Drive Winchester, MA 01890 USA Telephone (781) 721-2921 email: [email protected]

Copyright © 2012 Crisis Prevention and Recovery, LLC

Mar 2012 ­ July 2012

SoftwareCPR.com Newsletter

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Newsletter Instructions The NEW items listed on the following pages are organized according to their location in the REFERENCE section of www.softwarecpr.com . Some sections of this newsletter provide a complete index, others just recently added items. If you have trouble finding an item of interest, send email to [email protected] Note: Items with the "$" symbol on the website including most of items in the Educational Documents category are only accessible to those with valid logins. If you are not a subscriber, and would like more information on becoming one, right click Subscription Page. SoftwareCPR® Consulting and Annual Subscriptions SoftwareCPR® provides training in FDA regulation, risk management, and software validation. Alan Kusinitz of SoftwareCPR® has provided in-house training to FDA and Health Canada and is on the AAMI Software Committee and involved in international software standards. Sherman Eagles chairs many of the international software working groups. Several other SoftwareCPR® partners have been involved in development of FDA recognized standards for medical device software and EU software guidance. Consider having us update you on current regulatory expectations. SoftwareCPR® also performs auditing, consulting and crisis management for all aspects of FDA regulation including quality systems, design control, and premarket submissions as well as hands-on support for risk management and validation. Remember if you are a paid subscriber you can submit questions on the website for guaranteed response from one of our experts, obtain word copies of any of our posted educational aides, and can receive all of our bulletins and newsletters. If you are not a paid subscriber more information about the value of subscribing, including the premium Standards Navigator subscription, is available at http://www.softwarecpr.com/subscriptionramepage.HTM .

Software Regulatory News (recently added news updates only)

7/27/12 - China SFDA Draft Software Premarket Requirements 7/11/2012 - FDA Clinical Data for Imaging Diagnosis submission 7/1/2012 - MDICC draft concept paper 5/29/2012 - Calculation software recall reclassified Class I 5/29/2012 - FCC allocates spectrum for wireless medical device 5/22/2012 - EU 62304 Conformity FAQ Invitation Letter 5/16/2012 - AAMI Software and Health Information Technology 4/27/2012 - Sherman Eagles wins ACCE award 4/12/2012 - FDA Final 513(g) Guidance Requests for Information 3/27/2012 - IEC 62366 Fast Track Amendment Proposal 3/6/2012 - Software Recall Summary 2004-2011

FDA Documents (recently added or updated software related items only)

FDA Inspection Issue Terminology FDA Clinical Data for Imaging Diagnosis submission FDA Inspection Issue Terminology AAMI Software and Health Information Technology Paper copies of Electronic labeling Veterinary products FDA Final 513(g) Guidance Requests for Information FDA Clinical Decision Support SW Presentation FDA Mobile Medical Apps Presentation

20 Berkshire Drive Winchester, MA 01890 USA Telephone (781) 721-2921 email: [email protected]

Copyright © 2012 Crisis Prevention and Recovery, LLC

Mar 2012 ­ July 2012

SoftwareCPR.com Newsletter

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LIBRARY SoftwareCPR® Educational Material (RECENTLY ADDED OR UPDATED ITEMS ONLY) BROWSE OR SEARCH THE WEBSITE LIBRARY or TOPICS FOR THESE AND MANY OTHERS

· · · · · · SoftwareCPR® EN 62366 Usability Standard Checklist $China SFDA Draft Software Premarket Requirements English Translation$ $All Recall Excerpts in one pdf file$ $All Warning Letter Excerpts in one pdf file$ Part 11 Warning Letter Excerpts in one pdf file$ AAMI Agile Methods TIR - SoftwareCPR® Presentation

Conferences and Public Training (a few recent and upcoming FDA software related conferences)

9/13/2012 - *NCBA Conference - MDDS and IEC 80001-1* 10/22/2012 - *AAMI Assurance Case Course* 1/1/2012 - *SoftwareCPR Tailored Training at your site* *Conferences with SoftwareCPR® speakers are in bold

Warning Letters (recently added software- related FDA warning letters)

7/25/2012 - $All Warning Letter Excerpts in one pdf file$ 7/12/2012 - Part 11 Warning Letter Excerpts in one pdf file$ 6/15/2012 - Shamrock Medical Solutions Group LLC 6/14/2012 - American Optisurgical Inc. 6/11/2012 - Oertel Medical GmbH 6/5/2012 - Michigan Medical Innovations 5/23/2012 - Tango3 LLC 5/10/2012 - BTS S.p.A. FreeEMG and PocketEMG 5/8/2012 - Mediagnost GmbH 5/2/2012 - Amplivox Limited 3/28/2012 - Osypka Medical GmbH 3/28/2012 - SystemsOne, LLC 3/7/2012 - Prosec Protection Systems, Inc.

20 Berkshire Drive Winchester, MA 01890 USA Telephone (781) 721-2921 email: [email protected]

Copyright © 2012 Crisis Prevention and Recovery, LLC

Mar 2012 ­ July 2012

SoftwareCPR.com Newsletter

Page 4 of 5

Recalls (recently added software-related recalls published by FDA)

7/26/2012 - $All Recall Excerpts in one pdf file$ 7/25/2012 - GE Optima Mobile X-ray System, Cl ll 7/25/2012 - Hitachi Scenaria CT System Software, Cl ll 7/25/2012 - SIGMASpectrum Drug Library software Cl lll 7/23/2012 - Philips Healthcare Faulty Patient Data Exchange 7/18/2012 - GE Advantage CT/PET Fusion Software Cl ll 7/18/2012 - InstaTrak with Multiple Dataset Navigation, Cl ll 7/18/2012 - Intellispace Portal software, Cl ll 7/18/2012 - Intellispace Portal& Extended Brillance SW Cl ll 7/18/2012 - Philips HeartStart MRx M3536A Defibrillator Cl ll 7/18/2012 - Philips Intellispace Portal software, Cl ll 7/18/2012 - superDimension Systems AAS00016-xx, Cl ll 7/11/2012 - Maquet Medical Systems FLOW-i Anesthesia Sys Cl l 7/11/2012 - Philips Xcelera Connect, Software Cl ll 6/27/2012 - Medtronic 0-arm Imaging System , Cl ll 6/27/2012 - Spacelabs Pathfinder SL , Cl ll 6/18/2012 - Expanded Recall SIGMA Spectrum Infusion Pump Cl l 6/14/2012 - Brilliance iCT and iCT SP, Cl ll 6/7/2012 - Becton Dickinson Phoenix" , Cl ll 6/7/2012 - Siemens brand ACUSON S2000 Ultrasound System Cl ll 6/7/2012 - VITROS 5600 Integrated System Software, Cl ll 6/7/2012 - XiO Radiation Treatment Planning, Cl ll 5/31/2012 - ACUSON S1000 ultrasound SW version 1.0, Cl ll 5/31/2012 - Ingenuity TF PET/MRI System v.3.7.1, 510(k), Cl ll 5/31/2012 - Philips Digital Diagnost Systems Eleva SW, Cl ll 5/31/2012 - SafeTrace Tx, Cl ll 5/31/2012 - Siemens Vista(R) software version 3.4, Cl ll 5/31/2012 - TrueBeam and True Beam STx versions, Cl ll 5/30/2012 - Reclassified: Baxa Abacus SW, Cl l 5/24/2012 - Fresenius Liberty Cycler Software, Cl ll 5/24/2012 - Insight rev H software, Cl ll 5/24/2012 - Philips Digital Diagnost Systems, Cl ll 5/24/2012 -Trima Accel Automated Blood Collection, Cl ll 5/24/2012 - Varian True Beam, Cl ll 5/18/2012 - MEDITECH Anatomical Pathology Software, Cl ll 5/18/2012 - Philips eCareManager System, Cl ll 5/10/2012 - FastPlan Treatment Planning System, Cl ll 5/4/2012 - Brillance & Gemmini Tomography Xray Systems, Cl ll 5/4/2012 - TeleSentry Ambulatory Telemetry, Cl ll 5/4/2012 - Viterion 100-BGM TeleHealth Monitor, Cl ll 5/4/2012 - VITROS ECi Immunodiagnostic System, Cl ll 5/24/2012 - Insight rev H software, Cl ll 5/24/2012 - Philips Digital Diagnost Systems, Cl ll 5/24/2012 -Trima Accel Automated Blood Collection, Cl ll 5/24/2012 - Varian True Beam, Cl ll 5/18/2012 - MEDITECH Anatomical Pathology Software, Cl ll 5/18/2012 - Philips eCareManager System, Cl ll 5/10/2012 - FastPlan Treatment Planning System, Cl ll 5/4/2012 - Brillance & Gemmini Tomography Xray Systems, Cl ll 5/4/2012 - TeleSentry Ambulatory Telemetry, Cl ll 5/4/2012 - Viterion 100-BGM TeleHealth Monitor, Cl ll 5/4/2012 - VITROS ECi Immunodiagnostic System, Cl ll 4/26/2012 - Brilliance Workspace IntelliSpace Portal, Cl ll 4/26/2012 - OneTouch Verio IQ Blood Glucose Monitoring, Cl ll 4/18/2012 - Baxa Pharmacy compounding system, Cl ll 4/18/2012 - EasyLink(TM) Informatics Systems, Cl ll 4/18/2012 - GE Healthcare Innova X-ray Imaging Systems, Cl ll 4/18/2012 - MultiDiagnost Eleva IITV w/Software Release,Cl ll 4/18/2012 - OneTouch(R) Ping(R) Insulin Pump, Cl ll 4/12/2012 - Brilliance 64 & Ingenuity CT Xray Systems, Cl ll 4/12/2012 - Medtronic Model 8870 Application SW Card Cl ll 4/12/2012 - RayStation Version 2.0.0.15, Cl ll 4/4/2012 - Brilliance Workspace Port, Cl ll 4/4/2012 - MOSAIQ System, Cl ll 4/4/2012 - QRS Diagnostic Universal ECG 12 Channel ECG, Cl ll 3/29/2012 - Elecsys 2010 Analyzer Software, Cl ll 3/29/2012 - NicoletOne Software v 5.60.2-5.71.4 with Cl l 3/29/2012 - Philips MultiDiagnost Eleva Software, Cl ll 3/22/2012 - Philips MultiDiagnost Eleva FD Software, Cl ll 3/22/2012 - Retcam3 & Retcam Shuttle, Cl ll 3/22/2012 - ToshibaTSX-301A & TSX-301B: AQUILION ONE;, Cl ll 3/15/2012 - ARTISTE, ONCOR and PRIMUS Linear Accelerator Cl ll 3/15/2012 - Brillance and Ingenuity CT Systems, Cl ll 3/15/2012 - LATITUDE Patient management System, Cl lll 3/15/2012 - Microsoft Amalga, Cl ll 3/15/2012 - Siemens syngo Imaging XS, Cl ll 3/15/2012 - TruFlight Select PET/CT System, Cl ll 3/8/2012 - MIndray V Series Monitor, Cl ll 3/8/2012 - Philips Intellispace Portal, Cl ll 3/8/2012 - Siemens syngo.plaza, Cl ll 3/6/2012 - Software Recall Summary 2004-2011.

20 Berkshire Drive Winchester, MA 01890 USA Telephone (781) 721-2921 email: [email protected]

Copyright © 2012 Crisis Prevention and Recovery, LLC

Mar 2012 ­ July 2012

SoftwareCPR.com Newsletter

Page 5 of 5

Industry Papers/Presentations (RECENTLY ADDED OR UPDATED ITEMS ONLY) BROWSE OR SEARCH THE WEBSITE LIBRARY or TOPICS FOR THESE AND MANY OTHERS 2/28/2012 - Build and Validate Safety Article

Standards and Non-US Regulations (RECENTLY ADDED OR UPDATED ITEMS ONLY) BROWSE OR SEARCH THE WEBSITE LIBRARY or TOPICS FOR THESE AND MANY OTHERS · · · · Joint Initiative on SDO Global Health Informatics MDICC draft concept paper AAMI Agile Methods TIR - SoftwareCPR Presentation IEC 62366 Fast Track Amendment Proposal

20 Berkshire Drive Winchester, MA 01890 USA Telephone (781) 721-2921 email: [email protected]

Copyright © 2012 Crisis Prevention and Recovery, LLC

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