Regulatory Focus™ > News Articles > Final Guidance for Blood Product Testing Released by FDA

Final Guidance for Blood Product Testing Released by FDA

Posted 14 November 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released a final guidance regarding the use of nucleic acid tests (NATs) to reduce the transmission of hepatitis B, part of a strategy the agency says it hopes will assist in the screening of blood and plasma donors for the virus.

The final guidance comes nearly a year after the agency first released the draft version of the guidance. FDA said it considers Hepatitis B (HBV) NATs to be "necessary to reduce adequately and appropriately the risk of transmission of HBV."

"FDA-licensed HBV NAT can detect evidence of infection at an earlier stage than is possible using previously approved hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc) tests," FDA explained in its Federal Register posting. "Therefore, FDA is recommending the use FDA-licensed HBV NAT, in accordance with the requirements under Title 21 Code of Federal Regulations, 610.40(a) and (b) (21 CFR 610.40(a) and (b))."

Regulators said the new draft guidance serves to supplement other guidance documents concerning the testing of blood and plasma collections for hepatitis B. Those guidance documents are not superseded by FDA's NAT guidance, and testing should continue on samples using approved HBsAg and HBc tests, said FDA.

The Register notice explains that the final guidance differs from the draft guidance on several points, made in response to comments received by FDA. "In addition to minor editorial changes made to improve clarity, changes to the draft guidance include revised labeling recommendations and an extension of the time for implementation of the guidance to 6 months after publication of the final guidance," FDA explained.

The regulations apply to all blood establishments that collect whole blood and blood components for transfusion or further manufacture. Those components include recovered plasma, source plasma and source leukocytes, FDA said.


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