FDA
has issued a new guidance document in relation to blood. The document is titled
“Bacterial Detection Testing by Blood Collection Establishments and Transfusion
Services to Enhance the Safety and Availability of Platelets for Transfusion.”
In
summary, the scope is:
“This
draft guidance, when finalized, will represent the Food and Drug
Administration’s (FDA’s or Agency’s) current thinking on this topic. It does
not create or confer any rights for or on any person and does not operate to
bind FDA or the public. You can use an alternative approach if the approach
satisfies the requirements of the applicable statutes and regulations. If you
want to discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA staff,
call the appropriate number listed on the title page of this guidance.”
The
guidance is currently presented as a draft and is out for comments.
Posted by Tim Sandle
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