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COURSE DATES: June 4 – 6, 2019 TRAINING LOCATION: Boston, MA USA COST: 3 Full Days for $2,495.00 Limited number of “Early Bird” Discounted seats:  $1,795.00 Registration link Only a limited number of discounted seats are available.  For more information on the course, use the form below. This three-day course provides a clear understanding of...
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US FDA has proposed a new rule to exempt Cytometry instruments used for counting or characterizing cells (a well-understood and mature technology), from premarket notification requirements.  Cytometry instruments used for sorting or collecting cells, and instruments that are used as an automated hematology analyzer, or that perform automated differential cell counts, will still require premarket...
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Today FDA qualified the Osirix CDE Software Module biomarker test for use by medical device developers to identify and enroll patients into Traumatic Brain Injury (TBI) studies.  This is the third qualification of a medical device development tool (MDDT) by the FDA, and the first of a software module biomarker test tool type. A biomarker...
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Medical Device Development Tool (MDDT) Qualification The US FDA has provided guidance on the methods and approaches to qualify a medical device development tool so that medical device manufacturers or sponsors can use them to support the development and evaluation of medical devices.  The manufacturer is expected to ensure the tool produces “scientifically-plausible measurements” and...
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Our March 2019 Newsletter has been published.  Learn of significant regulatory and standards related activity associated medical device software, medical mobile apps, and HealthIT software.  Also you can find dates for upcoming training opportunities.
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For those currently or intending to distribute electronic labeling for their medical devices, be aware that in 2010 FDA issued a guidance entitled “Addition of URL to Electronic Product Labeling”.  This guidance contains a recommendation: “ …that manufacturers include their Uniform Resource Locator (URL) on their electronic product labels in addition to the requirements under...
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What does one need to know about IEC 62304? In our 3-day 62304 Training course, we flow through the software development lifecycle drawing attention to requirements of the standard as well as related standards and always current FDA expectations from our experience.  The topics we plan to cover in our 2019 course are below. Topics: Regulatory...
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The FDA released a Draft Guidance titled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments”, on February 19, 2019.  It provides a very limited set of conditions where companies can request non-binding FDA feedback to the adequacy of planned corrective actions. The request must be submitted within 15 days of the issuance of the...
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FDA issued a version of its “Refuse to Accept Policy for 510(k)s” dated 21-Feb-2019. This supersedes the prior 30-Jan-2018 version.  As FDA guidance goes, this a short period of time between updates.  It focuses on explaining the initial 15 day administrative completeness check, review initial questions, provision of a checklist for this administrative review which...
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Company: Elekta, Inc. Date of Enforcement Report: 2/8/2019 Class II: PRODUCT MOSAIQ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number: Z-0821-2019 REASON There...
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On Jan 14, 2019, FDA recognized ANSI AAMI SW91:2018 Classification of defects in health software.  The FDA recognition statement for this standard does not indicate any specific use in premarket submissions or relevant FDA guidances. It simply states it supports existing policies.  This standard is lengthy and technical in terms of its approach to defect...
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Through blog posts and downloadable content, Alan Kusinitz, Sherman Eagles, Brian Pate, and other SoftwareCPR® experts keep you informed of new developments in FDA Software Regulation, enforcement actions, ISO standards related to medical devices, and also gain access to a wide variety of training aides, document templates, and checklists! Download the attached form to learn more about the different SoftwareCPR® subscriptions...
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Company: Medtronic, Inc. Date of Enforcement Report: 1/17/2019 Class I: PRODUCT Medtronic’s Dual Chamber Implantable Pulse Generators (IPGs) are implanted cardiac pacemakers used to provide stimulation to increase heart rate in patients with a slow heart rhythm (bradycardia) or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other...
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Company: GE Healthcare, LLC Date of Enforcement Report: 2/1/2019 Class II PRODUCT GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of...
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Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 2/1/2019 Class II PRODUCT MEDTRONIC CARELINK 2090 programmer Recall Number: Z-0795-2019 REASON There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its...
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Company: GE Healthcare, LLC Date of Enforcement Report: 2/6/2019 Class II PRODUCT Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall Number: Z-0776-2019 REASON On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation...
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Company: NEUSOFT MEDICAL SYSTEMS IMP & EX Date of Enforcement Report: 2/5/2019 Class II PRODUCT NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY...
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Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 2/1/2019 Class II: PRODUCT MEDTRONIC CARELINK 2090 programmer Recall Number: Z-0795-2019 REASON There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its...
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Company: GE Healthcare, LLC Date of Enforcement Report: 2/6/2019 Class II: PRODUCT Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall Number: Z-0776-2019 REASON On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation...
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Company: NEUSOFT MEDICAL SYSTEMS IMP & EX Date of Enforcement Report: 2/5/2019 Class II: PRODUCT NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY...
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Company: Becton, Dickinson and Company, BD Biosciences Date of Enforcement Report: 2/1/2019 Class III: PRODUCT BD FACSLyric(TM) 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric(TM) is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell...
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Company: Radiometer America Inc Date of Enforcement Report: 2/5/2019 Class II: PRODUCT Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845. Recall Number: Z-0801-2019 REASON From three incidents in Denmark...
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Came across this website that has some very detailed “commandments” for software development at their company.  A surprisingly lengthy list of dos and don’ts related to coding, testing, designing, estimating, and managing the software lifecycle.  Does your company have anything written?  I often find that each company has some “lore” – some practices that characterize...
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Datascope Corporation Product: Medical Device Date: 2/6/19 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 1300 Macarthur Blvd., Mahwah, NJ, from July 30, 2018 through October 3, 2018. During the inspection, FDA investigators determined that your firm is a of intra-aortic balloon pumps (IABPs) and Cardiosave...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 1/29/2019 Class II PRODUCT Atellica IM 1300 Analyzer; In-vitro diagnostic testing of clinical specimens; Siemens Material Number (SMN): 1066001 Product Usage: The Atellica Solution is a multi-component system for in-vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of...
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The US FDA issued the final guidance for industry, “The Least Burdensome Provisions: Concept and Principles.”  This guidance is intended to accurately reflect Congress’ intent by describing the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles.  FDA Least Burdensome Final Guidance
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FDA posted a Stryker announcement today that the company is launching a voluntary field action (VFA) on specific units of the LIFEPAK 15 Monitor/Defibrillators. The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as...
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Company: Varian Medical Systems, Inc. Date of Enforcement Report: 1/24/2019 Class II PRODUCT Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon,...
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Company: Stryker Sustainability Solutions Date of Enforcement Report: 1/23/2019 Class II PRODUCT BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Recall Number: Z-0766-2019 REASON Stryker s Sustainability Solutions division (SSS)...
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Does FDA accept regulatory submissions for medical devices and SaMD that have software developed using agile methods? What about IEC 62304 compliance?  Can agile and lean approaches to software development be compliant? On February 18th and 19th, 2019, we will explore those topics and more at our 2019 “Being Agile & Compliant” public training course. ...
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COURSE DATES: February 18 – 19, 2019 TRAINING LOCATION: Tampa, Florida, USA COST: 2 Full Days for $2,495.00 January Registration Discount of 10% available through Jan 19, 2019. Extended to 1/25/2019. Ask about our multi-student discount as well! Meet our newest partner, John Murray, at the course! Download registration form Only a limited number of...
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FDA is entering the test phase of its Digital Health Precertification (Pre-Cert) Pilot Program. General information on this program can be found at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htm including FAQs at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm577330.htm Milestones and next steps can be found at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm584020.htm Generally, this program is for some of what FDA refers to as Software as a Medical Device (SaMD). ...
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Company: Philips Medical Systems Nederlands Date of Enforcement Report: 1/8/2019 Class II PRODUCT Ingenia Elition S, Ingenia Elition X Recall Number: Z-0694-2019 REASON During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement. RECALLING FIRM/MANUFACTURER Philips Medical Systems Nederlands, Best, Netherlands on 12/3/2018. Voluntary:...
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Company: Agfa-Gevaert, N.V. Date of Enforcement Report: 1/7/2019 Class II PRODUCT DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 12/29/2018 Class II PRODUCT GE Magnetic Resonance System Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use Recall Number: Z-0693-2019 REASON Possible incorrect software version loaded. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC, Waukesha, WI on 11/15/2018. Voluntary: Firm Initiated...
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It’s nice to have medical device FDA regulations and guidance accessible without navigating through old websites or lugging printed copies around. Thankfully, SoftwareCPR’s free iOs and Android apps allow you to quickly view medical device regulations and guidance on your smartphone offline! As medical device consultants, we know from experience how important it is to...
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(January 7, 2019)— John F. Murray, Jr, of Mount Airy, MD USA, has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®) as a partner. John retired from the US Food and Drug Administration in December 2018 after 32 years of federal service. For 25 years at FDA, John focused on FDA regulated software and...
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Company: Hologic, Inc. Date of Enforcement Report: 12/27/2018 Class II PRODUCT I-View Contrast Enhanced Digital Mammography, ASY-08109 Recall Number: Z-0685-2019 REASON Calibration issue not possible to visualize contrast uptake in the subtracted mammography images RECALLING FIRM/MANUFACTURER Hologic, Inc., Danbury, CT on 12/6/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 337 units...
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Company: Elekta, Inc. Date of Enforcement Report: 12/27/2018 Class II PRODUCT MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery Recall Number: Z-0686-2019 REASON If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup...
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Company: Radiometer America Inc Date of Enforcement Report: 12/22/2018 Class II PRODUCT ABL800 analyzer, model numbers 393-800 and 393-801. Recall Number: Z-0682-2019 REASON The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur. RECALLING FIRM/MANUFACTURER Radiometer America Inc, Brea, CA on 7/3/2018. Voluntary: Firm Initiated...
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Company: Medtronic Inc. Date of Enforcement Report: 12/22/2018 Class II PRODUCT Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International) Recall Number: Z-0683-2019 REASON Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 12/29/2018 Class I: PRODUCT StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide – Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733068) Note: This device is...
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Company: GE Healthcare, LLC Date of Enforcement Report: 12/19/2018 Class II PRODUCT Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect. Recall Number: Z-0641-2019 REASON Issue #1 affects Software Versions 6.0 SP7,...
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Company: ICU Medical Inc Date of Enforcement Report: 12/17/2018 Class II PRODUCT SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient’s epidural space. Sets are intended for use with Sapphire Infusion Systems. Recall Number:...
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Company: bioMerieux, Inc. Date of Enforcement Report: 12/19/2018 Class II PRODUCT VITEK 2 Systems Software Version 9.01 Update Kit. Recall Number: Z-0639-2019 REASON The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP” feature. RECALLING...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 12/20/18 Class II PRODUCT VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid. Recall Number: Z-0651-2019...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 12/20/18 Class II PRODUCT VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Recall Number:...
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Company: Philips Electronics North America Corporation Date of Enforcement Report: 12/14/2018 Class II PRODUCT Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 Recall Number: Z-0614-2019 REASON There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed....
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 12/14/2018 Class II PRODUCT Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Recall Number: Z-0616-2019 (Vista 500, Model...
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Company: Tosoh Bioscience Inc Date of Enforcement Report: 12/14/2018 Class II PRODUCT AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the...
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