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  #1  
January 12th, 2016, 03:01 PM
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FDA Jurisdiction Organs

hii sir, I heard from some where about the Blood vessels recovered with organs and intended for use in organ transplantation please provide me the details about this transplantation ?
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  #2  
January 12th, 2016, 03:08 PM
Super Moderator
 
Join Date: Mar 2012
Re: FDA Jurisdiction Organs

As you asking for the organ transplantation by the Blood vessels let me tell you that the The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are amending their regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products (HCT/Ps) (FDA regulation). We (HRSA and FDA) are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation are governed by the regulations pertaining to organ

Blood vessels recovered with an organ, as defined in 42 CFR121 .2,
that are intended for use in organ transplantation and labeled "For use in organ
transplantation only ." ,


Organ * * * Blood vessels recovered from an -organ. donor during the
recovery of such organ(s) are considered part of an organ with which they are
.
13
procured for purposes of this part if the vessels are intended for use in organ
transplantation and labeled "For use in organ transplantation only


rest of the details you may found from the file given below :

Blood vessels recovered with organs and intended for use in organ transplantation








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