Regulatory Focus™ > News Articles > FDA Releases Draft Guidance Changing Blood Donation Criteria

FDA Releases Draft Guidance Changing Blood Donation Criteria

Posted 06 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released new draft guidance intended to reduce the risk of transmitting malaria through donated blood.

In its 6 June Federal Register posting, FDA said the draft guidance document addresses donor testing, as well as managing donor deferrals and reentry into the pool of blood donors. The purpose of the draft guidance is to "reduce the risk of transfusion-transmitted malaria," FDA wrote in the posting.

"This draft guidance document also provides recommendations for product management, including recommendations regarding product retrieval and quarantine, and notification of consignees of blood and blood components in the event that a blood establishment determines that blood or blood components have been collected from a donor who should have been deferred due to possible malaria risk," FDA added.

FDA also explained the guidance will revise its policy of banning the donation of blood by any donors who have traveled to the Mexican states of Quintana Roo or Jalisco, "provided the donor meets all other donor eligibility criteria."

The draft guidance is set to replace a 1994 guidance by a similar name, Recommendations for Deferral of Donors for Malaria Risk.

The recommendations do not apply to Source Plasma, but rather only to blood products. Comments are due by 6 September 2012.

Read more:

FDA - Draft Guidance for Industry: Donor Questioning, Deferral, Reentry, etc. to Reduce Risk of Transfusion-Transmitted Malaria


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