By

Alan Kusinitz
National Law Review discusses a case before the EU Court of Justice to decide if medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device. The manufacturer prefers it to be considered a medical device to avoid more onerous requirements if it is not treated that way.
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM524904.pdf
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http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM519346.pdf
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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 Part 11 related warning letter excerpts included on this site as of the date above.  This file is updated periodically, but for the most recent warning letters between these updates, do text...
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM512648.pdf
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http://www.fda.gov/MedicalDevices/DigitalHealth/ucm512245.htm
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See the item on the MDR Trilogue Agreement for further explanation.  The text for the IVD draft is a the link provided here: EU IVDR.
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This document is the result of an industry-led initiative of the European Commission. It is targeted at app developers and its purpose is to foster justified trust among users of mHealth apps which process personal data. Standards Navigator Draft Health Code of Conduct
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/docs/scpred/standardsnavigator/EU_Data_Protection_Regulation.pdf
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/docs/scpred/SoftwareCPR-Newsletter052016.pdf
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/docs/scpred/SoftwareCPR-LatestNewsletter.htm
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The US FDA issued a draft guidance entitled: “Use of Electronic Health Record Data in Clinical Investigations”. This draft addresses a variety of issues including EHRs certified by ONC, data modifications, audit trials, informed consent, and Privacy and Security. The full draft guidance can be found at the following link: FDA_Use_of_EHR_Data_in_Clinical_Investigations
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm504091.pdf
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM268141.pdf
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http://www.gpo.gov/fdsys/pkg/FR-2016-04-04/html/2016-07467.htm
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http://www.gpo.gov/fdsys/pkg/FR-2016-04-04/html/2016-07467.htm
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On March 29, 2016, the US Department of Homeland Security issued an Advisory regarding the Carefusion Pyxis SupplyStation System Vulnerabilities that would only require an attacker with low skills.  Specific mitigations listed in the Advisory include: Isolate affected products from the Internet and untrusted systems; however, if additional connectivity is required, use a VPN solution....
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The link provided is our revised checklist for changes in Amendment 1. You will need to login as a paid subscriber to download this checklist.
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Amendment 1 of” “IEC 62304 Medical device software — Software Life cycle processes” was issued in 2015. Although the focus of the Amendment was to include a special provision for Legacy software as well as clarifications and changes to Safety Classification, a number of other substantive changes were made.including significant additional requirements for Class A...
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/docs/scpred/FDA-2015WL-483DataPresentationV_1312016.pdf
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/docs/scpred/FDA-2015WL-483DataPresentationV_1312016.pdf
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How does one know what standards are helpful when creating or updating your software development process? Can compliance with standards benefit a medical device or HealthIT company with regulatory approval and/or FDA inspections? These questions and more will be answered at the upcoming 62304 training and emerging standards impacting Medical Device software and Health IT...
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The Final Draft International Standard was approved at the end of 2015 and will be submitted for publication. The standard is expected to be published by the end of March 2016.  A three year transition period has been proposed.
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http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm484914.pdf
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/docs/FDAhighestprioritydevices4humanfactorsreview0216.pdf
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NOTE: This is for historical reference as a final guidance was issued Sept 2017 and is posted separately. FDA issued a new draft guidance entitled “Design Considerations and Pre- market Submission Recommendations for Interoperable Medical Devices”. This guidance addresses medical devices that exchange information whether wired or wireless including through the internet. It includes unidirectional...
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FDA held a two day public cybersecurity workshop Jan 20-21,2016.   See the output, including links to the webcasts, from the workshop sessions.
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Sherman Eagles of SoftwareCPR expects increased standards and regulatory activity related to Software and HealthIT in 2016. Here are some of the areas to watch: IEC 82304-1 Health Software: General requirements for safety will be completed during the first half of 2016. It is intended that this standard be harmonized in the EU, but it...
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Note:  This draft is OBSOLETE and included only for historical reference only.  Look for the final draft elsewhere on this site. To view the guidance click this link:  2016-01-FDA Post market Cybersecurity draft guidance This guidance references a number of Presidential Executive Orders related to critical infrastructure and cybersecurity as a driving force for FDA’s increased oversight...
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FDA held a public workshop, “Collaborative Approaches for Medical Device and Healthcare Cybersecurity,” October 21-22, 2014, in partnership with the Department of Homeland Security. The program book issued by FDA after the workshop was held is at the link provided. It contains information on the sessions, objectives, and speaker biographies. Sherman Eagles of SoftwareCPR® was...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. It contains a training aid that provides an overview comparison between the 2015 Amendment of IEC 62304 and FDA requirements based on 62304 Safety Classes. SCPRed_SoftwareCPR-FDA-62304SafetyClasscomparisonTrainingAide
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm
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The International Society of Pharmaceutical Engineering publishes the Good Automated Practices Guides including GAMP from 2008 which coverscomputer system validation in general and a number of more recent guides on topics ranging from mobile apps to IT infrastructure control. The current list of available guides is: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized...
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In July 2015 an amendment was issued to IEC 62304. While this amendment was focused on additions for Legacy software and clarifications to the use of risk in safety classification keep in mind that a number of other smaller changes and additions were made. Some of the more significant ones include: 1. Reduction in the...
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In July 2015 an amendment was issued to IEC 62304. While this amendment was focused on additions for legacy software and clarifications to the use of risk in safety classification, keep in mind that a number of other smaller changes and additions were made. Some of the more significant ones include: Reduction in the exemptions...
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http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm313794.pdf
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Although FDA’s Device Center tends to exempt many Mobile Medical Apps from regualtion FDA’s Drug Center has its own approach. Our current understanding is that mobile apps distributed with drugs are considered part of a combination product in many cases and the Drug Center will review the MMApp information as part of the product approval...
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http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm468246.htm
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A new International Medical Device Regulators Forum (IMDRF) document was finalized.  It is Software as a Medical Device (SaMD): Application of Quality Management System.  The objective of the document is to provide guidance on the application of existing standardized and generally accepted QMS practices to SaMD. View the document at this link:  imdrf-tech-151002-samd-qms
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Paul Felten of SoftwareCPR has successfully passed the ISTQB Agile Tester Certification exam. The ISTQB Agile Tester certification was created to account for new emerging practices and methodology changes in the software testing industry. Based on the foundation level syllabus, this certification ensures that software testers and professional alike have the necessary knowledge and skills...
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM396595.pdf
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http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm457581.htm
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https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edition-health-information-technology-certification-criteria-2015-edition-base-electronic
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