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/ComputerizedLaborMonitoringSystemGuidance042407.pdf
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/Docs/ComputerizedLaborMonitoringSystemClassificationRule042407.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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Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

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