By

Alan Kusinitz
A new version of EN 14971 was published and harmonized in the Official Journal of the EU. ISO 14971 now may not ensure compliance with EU essential requirements for medical devices. Specifically, 14971 allows the manufacturer to disregard negligible risks; but all risks must be taken into account and reduced as much as possible to...
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/Docs/scpred/standardsnavigator/GAO_FDA_security_report.pdf
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Draft of the revised IVDD is at the link provided. EU Proposed New IVD
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An FCC mHealth task force reported recommendations to government and industry to address barriers to rapid mHealth deployment. See the link provided: FCC 2012 Mhealth Taskforce Recommendations.
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Draft of the revised MDD is at the link provided. The existing Active Implantable Device Directive is incorporated into the new MDD. EU Proposed New MDD
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http://www.aami.org/meetings/courses/trainer.details.html
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http://lms.ulknowledgeservices.com/catalog/display.resource.aspx?resourceid=411809
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FDA issued a list of modifications to its standards recognitions. The link provided is the webpage where FDA posts each modification list.
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Mary Decareau of SoftwareCPR prepared a tiered checklist for EN 62366 Medical devices – Application of usability engineering to medical devices for our internal use and we are making it available to paid subscribers at the link provided and...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The SFDA prepared a draft document entitled “Explanations on the Basic Requirements of Application for Registration of Medical Device Software” on April 28, 2012, which is linked below. This was initially translated to English by JIRA (Japan Industries Association...
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FDA released a new guidance dated July 3, 2012 entitled ” Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions. This guidance discusses types of Computer Aided Detection devices (CADe) and appropriate clinical data to include in 510(k)s and...
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The link provided is to the Official US Government Web Site for the Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs. The terms EHR and Electronic Medical Record(EMR) are sometimes used interchangeably. The issue of what systems FDA does now or might in the future regulate as a medical device is not addressed via...
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This link provides a ten-year strategy document for information technology use in healthcare in England. NHS Power of Information
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The pdf at the link provided contains slides from a presentation by Brian Pate providing an overview of the soon to be released “Agile Methods for Medical Device Software Development” Technical Information Report (TIR). These slides focus on the TIR. We have posted another slide set in our library with some training slides on SoftwareCPR...
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http://www.fda.gov/iceci/inspections/fieldmanagementdirectives/ucm061430.htm
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The FCC voted to allocation special seperate wireless spectrum for devices implanted or attached to the the body for monitoring purposes.
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The Association for the Advancement of Medical Instrumentation (AAMI) is reorganizing its committee structure related to Software, Health IT, networks and related topics by forming a Software and Health Information Technology (SWIT) committee to oversee all related standards activities. The current plan is that this committee will coordinate all work in the Software, IT, MDDS,...
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While FDA has oversight over Medical devices for vetinary use they are not treated like devices for human use. Generally a quality system although recommended is not required and unless the device emits radiation registration and listing is not required. Below is an excerpt from the FDA website: How FDA Regulates Veterinary Devices The Federal...
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Recipient: Mediagnost GmbH. Product: Human Growth Hormone diagnostic kits Date: 5/8/12 Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40. For example: a. There are no procedures that address the control of electronic records. b. Access to two computer workstations that include in-process test data, finished device...
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109203.pdf
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The American College of Clinical Engineering issued its ACCE 2012 Challenge Awards. Sherman Eagles of SoftwareCPR received an award achievement in the field of health technology management for his leadership of the working groups for IEC 80001-1 for risk management of IT networks that incorporate medical devices and the AAMI Medical Device Data System-MDDS/Quality Systems...
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Recipient:Community Blood Centers of Florida, Inc. . Product:blood and blood components Date: 4/7/2012 The Food and Drug Administration (FDA) conducted an inspection of your firm, Community Blood Centers of Florida, Inc., from September 1, 2011 – December 19, 2011. During the inspection, FDA investigators documented deviations from applicable current Good Manufacturing Practice for Finished Pharmaceuticals...
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/docs/FDA-StandaloneClinicalDecisionSupportSystemPresentation091211.pdf
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/docs/FDA-mobile-apps-draft-guidancePresentation.pdf
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An article on the QMED website reporting on hacking of Medtronic Infusion pumps using remote wireless capability that could allow patient harm.
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The article “Build and Validate Safety in Medical Device Software”, available on the Medical Electronics Design Website at http://www.medicalelectronicsdesign.com or at the link provided above, provides an overview of the challenges and approaches to preventing and detecting software faults that can lead to hazardous situations. The article provides an overview of some of the relevant...
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Recipient:Biochem Laboratories Inc. Product:TX1 Tissue Removal System Date: 2/17/2012 Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 CFR 211.68(b)]. For example: a. Your firm did not put in place requirements...
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http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202511.htm
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The Institute of Medicine report is at the link provided. Health IT and Patient Safety Report
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For devices where the medical device manufacturer intends to maintain remote access capability for service and updates, controls are needed to ensure this access does not compromise the security or operation of the device. There is one FDA recognized standard that addresses this for clinical laboratory devices, but many of the provisions could be instructive...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf file contains all software and computer related warning letter excerpts included on this site. Some of the newest warning letters on the site may not be included since we only update this comprehensive document periodically. This...
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The Joint Initiative on SDO Global Health Informatics Standardization is formed to enable common, timely health informatics standards by addressing and resolving issues of gaps, overlaps, and counterproductive standardization efforts.
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/docs/SoftwareCPRNewsbefore2012not-also-in-Library.pdf
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/docs/JMurray-FDApresentation-SoftwareRAPSIndianapolisOctober2011.pdf
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IEC Technical Committee 62 established a Software and Network Advisory Group at its meeting in September. Sherman Eagles of SoftwareCPR was named chair of this 7-member international advisory group. The purpose of the group is to advise the TC Chairman and other TC and sub-committee officers on the need for software standards for medical devices,...
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/docs/scpred/SafetyAssuranceCaseUpdate0911.pdf
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SoftwareCPR participates in standards development and provides a premium subscription to provide additional insight and access to the development of new standards. The link, In Play 2011-09, is to one of Standards Navigator subscriber documents titled, “In play: The changing health and medical device software standards landscape.” This is updated regularly and includes the changes and new standards...
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FDA issued an analysis of Premarket Review Times under the 510(k) Program. In two samples of submissions it analyzed software deficiencies in the submissions were noted in 14-20% of the submissions analyzed. The deficiencies included no software documenation provided, missing software description, missing trace matrix, missing list of anomalies, and/or missing validation. In addition form...
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