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fda
Status of FDA permission requirements for Blood Bank establishment use of electronic crossmatch as of November 18, 1999: Because 21 CFR 606.151 requires a serologic crossmatch those hospitals (all hospitals) who wish to use the electronic crossmatch must apply for a variance to 21 CFR 606.151 (as allowed by 21 CFR 640.120) to gain written...
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/Docs/FDApresentationonPart11ANDClinicalTrialsSW.pdf
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FDA CDRH Office of Device Evaluation standards recognition statement for ” IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements For safety; 4. Collateral Standard: Programmable electrical medical systems”. FDA did not choose to recognize this standard for software submissions or even outright for risk management. They did issue a recognition statement explaining their...
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/Docs/CBERnew510kparadigmslides4perpage.pdf
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http://www.fda.gov/cdrh/ode/noninvas.html
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