Day

December 20, 2017
A draft of a new revision of the NIST Framework for Improving Critical Infrastructure Cybersecurity has been circulated for comment.  This draft (NIST_cybersecurity_framework-v1-1) revision refines, clarifies, and enhances Version 1.0 issued in February 2014.  This is a draft for comment. See copy of draft NIST Cybersecurity Framework v1-1
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Today the FDA is announcing the availability of the updated final guidance, “Medical Device Accessories – Describing Accessories and Classification Pathways”. This guidance was updated and replaces the Jan 2017 version to include new mechanisms to request (1) a different classification for an existing accessory type (i.e., accessories already on the market), and (2) for...
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Company:Normand InformatiqueDate of Enforcement Report 12/20/2017 Class lI: PRODUCT Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta...
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Company:Radiometer America Date of Enforcement Report 12/20/2017 Class lI: PRODUCT ABL800 analyzer with FLEXQ module.Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) – in...
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Company:Ortho-Clinical DiagnosticsDate of Enforcement Report 12/20/2017 Class lI: PRODUCT enGen Track System with TCAutomation Software Version 4.2 Recall Number Z-0254-2018 REASON A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN...
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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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