FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Revises Guidance on Reducing Risk of Zika Transmission by Blood

July 9, 2018
A A

The FDA released revised final guidance recommending ways for blood establishments to reduce the risk of transmitting the Zika virus through blood and blood components while meeting testing regulations.

In an August 2016 guidance, the agency recommended universal individual donation nucleic acid testing (ID NAT) for Zika virus. The revised guidance says blood establishments must test all donations collected in the United States and its territories with a licensed nucleic acid test, using either ID NAT or minipool (MP) NAT.

The revised recommendations are less burdensome for blood establishments because fewer tests will be performed when donations are tested by MP NAT compared to ID NAT. Alternatively, the agency said, blood establishments can use an FDA-approved pathogen reduction device.

View today's stories