FDA advises testing for Zika virus in all donated blood in the U.S.

August 26, 2016  |  FDA Medical Countermeasures Initiative Update

FDA now recommends testing all U.S. blood donations for Zika virus

As a further safety measure against the emerging Zika virus outbreak, on August 26, 2016, FDA issued revised guidance for reducing the risk of Zika virus transmission by transfusion of blood and blood components. FDA now recommends that all blood donations (Whole Blood and blood components) in the U.S. and its territories:

• Be tested with an investigational donor screening test for Zika virus,
• Be tested with a licensed screening test when available (no licensed screening tests are available at this time), or
• Be treated with an FDA-approved pathogen reduction device. (Currently, such technologies are available only for platelets and plasma.) 

Testing of donated blood is already underway in Florida and Puerto Rico, and it has shown to be effective in identifying donations infected with Zika virus.

Read the press release

Related Information

• Guidance for Industry: Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components (PDF, 279 KB)
• Zika response updates from FDA
• About regulation of the blood supply

Guidance and information for industry

• FDA is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. As part of proposed changes to this rule, FDA seeks comment on the impact of expanding part 58 to include coveredAnimal Rule studies, and what other changes to the regulations, beyond amending the scope and definitions, are needed to address issues unique to covered Animal Rule studies. Comment by November 22, 2016. (August 24, 2016) 

Events

• September 12-13, 2016: Public Hearing - Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products (Bethesda, MD and webcast)
• September 12-13, 2016: Public Workshop - Pediatric Clinical Investigator Training(Bethesda, MD and webcast) - Register by September 6, 2016
• September 13-14, 2016: Public Workshop - Sequencing Quality Control II (Bethesda, MD)
• New! September 14-15, 2016: FDA/UM Clinical Trials Symposium: Improving Clinical Research in the Age of Precision Medicine (Coral Gables, FL) (fee)
• September 23, 2016: Pediatric Master Protocols public workshop (Silver Spring, MD and webcast) - advance registration required (fee to attend in-person)
• New! September 23, 2016: Public Workshop - Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests (Rockville, MD and webcast) 

In case you missed it

• FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury (August 22, 2016)
• From the HHS blog - a simple way you can help us fight the Zika virus (August 17, 2016)