Brian Fitzgerald Deputy Division Director, Division of Electrical and Software Engineering, FDA CDRH, Office of Science & Engineering Laboratories, provided a list of software analysis tools FDA’s laboratory uses in evaluating medical device code. This was in response to a question posed at a recent AAMI Webinar that John Murray of FDA and Alan Kusinitz...Read More

In an AAMI Webinar John Murray of FDA indicated that it appears that software issues comprise 16 percent of medical device recalls and there is some thought to developing some special procedures for handling these. SoftwareCPR has found approximately 75 recalls related to software as of the end of November 2007 for the year which...Read More

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https://www.softwarecpr.com/docs/CBERbecsvalidationguidanceDraft1007.pdfRead More

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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. 21 CFR Part 11 is a topic of current focus for FDA and industry.  This manual contains the most important FDA documents related to Part 11 as well as some key SoftwareCPR educational Aides as listed below: This manual...Read More

/Docs/FDA-IOMerecordssection2007.pdfRead More

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http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html#2Read More

http://www.fda.gov/cdrh/osel/guidance/321.pdfRead More

/docs/FDAOIVD-IVDMIAdraftguidance072507.pdfRead More

/Docs/PulseOximeterDraftGuidance071907.pdfRead More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Our SoftwareCPR audit checklist for assessing conformance with the FDA Guidance for "Computerized Systems Used in Clinical Trials" can be viewed and downloaded at this link:  ClinicalTrialsSWFullChecklist. This checklist has been updated by Mary Decareau of SoftwareCPR to reflect...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. 21 CFR Part 11 is a topic of current focus for FDA and industry. In February 2003 FDA announced a major change in direction regarding Part 11 and withdrew all previous draft Part 11 guidance and the Part 11...Read More

/Docs/FDAClinicalTrialsComputerSystemGuidance-051007-04d-0440-gdl0002.pdfRead More

/Docs/ComputerizedLaborMonitoringSystemClassificationRule042407.pdfRead More

/Docs/ComputerizedLaborMonitoringSystemGuidance042407.pdfRead More

/docs/JMurrayPresentation-softwarecompliancescienceMarch2007.pdfRead More

/docs/FDAComplementaryandAlternativeMedicineProductsDraft2006.pdfRead More

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/Docs/FDAJMurray-SoftwareDesignControls041006.pdfRead More

/docs/IVDDFDARegulationofSoftwarePresentation1106.pdfRead More

/docs/Part11AdvaMednov82006finalA.pdfRead More

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/docs/FDAPortableInvasiveGlucoseMonitoring-DraftGuidance102406.pdfRead More

/Docs/BloodBank-FDA-CBER-CPG-0906.pdfRead More

FDA’s Center for Biologics Evaluation and Research issued the following: “Compliance Program Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002” This guide mentions software and computer systems in one paragraph which is provided below: “Computers: The performance of computer software must be validated (if customized) or verified (if used “off-the-shelf”) for...Read More

FDA announced in the Federal Register (Docket No. 1992S–0251) a central Gateway/single point of entry for electronic submissions for device, drug and biologic applications. It is referred to as the Electronic Submission Gateway (ESG). The announcement describes three secure options for electronic submissions: “The FDA ESG offers two secure communication options for applicants that have...Read More

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http://www.fda.gov/cdrh/oivd/presentations/042004-callaghan-software.html#footnote_2Read More

http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htmRead More

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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. This reference manual includes the following documents in a single pdf with bookmarks and a clickable TOC. Be sure to click bookmarks in adobe so you can jump around the document easily. This pdf contains key FDA software guidances...Read More

/docs/FDA-PATPresentationwatts_3_2005.pdfRead More

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22267.pdfRead More

http://www.21cfrpart11.com/pages/sol_prov/solution_providers.htmRead More

/Docs/ADVAMEDSoftware513(g)sFDASlides110205.pdfRead More

/docs/FDASoftwareSubmissionGuidance.pdfRead More

/docs/FDABFitzgeralsPresentationLondon04-2005.pdfRead More

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072331.pdfRead More

http://www.fda.gov/ohrms/dockets/dockets/04p0429/04p-0429-let0001-vol1.pdfRead More

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http://www.fda.gov/cdrh/osel/programareas/software.htmlRead More

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