Tag

devicecenter
/docs/FDAinfusionpumplifecycleguidance-ucm209337.pdf
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/docs/FDAFiscalYear2015userFeeRates.pdf
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/docs/FDACybersecuritySafetyCommunication061413.pdf
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/docs/FDA-StandaloneClinicalDecisionSupportSystemPresentation091211.pdf
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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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/docs/QSR21CFR820BasicIntroductionKTrautman0511.pdf
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/docs/MammographyGuidanceAddendum111610-UCM185904.pdf
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/docs/FDAInfusionPumpDraftGuidance-042310-UCM209337.pdf
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http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm187084.htm#7
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http://www.fda.gov/cdrh/devadvice/314.html
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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...
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/Docs/ComputerizedLaborMonitoringSystemClassificationRule042407.pdf
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/Docs/ComputerizedLaborMonitoringSystemGuidance042407.pdf
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/docs/FDAComplementaryandAlternativeMedicineProductsDraft2006.pdf
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/docs/IVDDFDARegulationofSoftwarePresentation1106.pdf
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/docs/CancelCellDetectionDeviceGuidance0904-Doc1531.pdf
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FDA has been investigating putting together information on hazards of various types of devices as an aide to both FDA and industry. Sandy Weininger at CDRH has established a forum for dissemination of information on this project. If you are interested in participating or receiving updates on this effort send email to office@softwarecpr.com or directly...
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/docs/UCIFDAJohnMurray-CDRHSoftwareMEssage101902.PPT
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Below is the classifcation rule. Note that this has been used for automated sample preparation systems of some types as well.TITLE 21–FOOD AND DRUGS CHAPTER I–FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 862_CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES–Table of Contents Subpart C_Clinical Laboratory Instruments Sec. 862.2050 General purpose laboratory equipment labeled...
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http://www.accessdata.fda.gov/cdrh_docs/pdf/k010605.pdf
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/Docs/FDA-DeviceLabelingandManualsGuidance.pdf
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As of 11/15/00 FDA CDRH formally recognizes “ANSI/UL 1998 Software in Programmable Components” for software submissions. Details of the recognition have not yet been posted by FDA as of 11/19/00 but the original intent was for this to be the first software standard to be recognized for devices with software of a MAJOR level of...
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/docs/GeneralPrinciplesOfSoftwareValidation.pdf
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http://www.fda.gov/cdrh/ode/noninvas.html
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/default.htm
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FDA CDRH Office of Device Evaluation’s “Draft Guidance for Implantable Cardioverter-Defibrillators Version 4.2” June 19, 1994. Section II.B addresses this so for documentation requirements for 510(k) submissions for this type of medical device by simply referring to the general software submission guidance and the Off-the-shelf software Submission guidance. Earlier versions of this draft at additional...
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