Sunday 11 January 2015

FDA: Bacterial Detection Testing by Blood Collection

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“This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this topic.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.

For details see: FDA

Posted by Tim Sandle

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