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Hi All
I intend to develop an "embryo transfer catheter" and manufacture it. As FDA prescribed, the device must undergo some testings like:
Thanks for your time
I intend to develop an "embryo transfer catheter" and manufacture it. As FDA prescribed, the device must undergo some testings like:
*mouse embryo assay (MEA)
*endotoxin testing (LAL)
*biocompatibility testing
*clinical testing
*and so on
(the whole regulations of this device is accessible in the "code of federal regulations title21" through §884.6110 )
Now the question: Where can i find the comprehensive protocol of each testing, for example what are the clinical testing items and MEA procedure?Thanks for your time