The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II); Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect Whole Blood and blood components with recommendations for a requalification method for deferred donors, based on a determination that their previous reactive test results for anti-HTLV-I/II were falsely positive.
Document
Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Recommendations for Requalification of Blood Donors Deferred Becau...
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83 FR 48448
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“Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II; Draft Guidance for Industry; Availability,” thefederalregister.org (September 25, 2018), https://thefederalregister.org/documents/2018-20775/recommendations-for-requalification-of-blood-donors-deferred-because-of-reactive-test-results-for-antibodies-to-human-t-.