deferral_rule: 6
Data license: Public Domain (CDC) · Data source: CDC Travelers' Health (Yellow Fever & Malaria, by country)
This data as json
| rule_id | source_id | code | exposure_type | geo_scope | threshold | deferral_window | description | citation | valid_from | valid_to | pathogen_reduction |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 | 2 | pathogen_reduction_alternative | travel | endemic_area_only | FDA-approved PR device effective against Plasmodium falciparum, per manufacturer IFU; platelet and/or plasma components only | none (replaces deferral) | Alternative procedure issued by the Director of CBER under 21 CFR 640.120(b) to the deferral provisions of 21 CFR 630.10(a) and (h). Platelet and/or plasma components may be collected WITHOUT a deferral period when pathogen-reduced using an FDA-approved PR device effective against P. falciparum (devices approved 2014), the device is used per its instructions for use, and the donor meets all other eligibility criteria. The carve-out covers only the two low-risk travel categories: (B.1) residents of non-endemic countries who traveled to an endemic area, and (B.3.b) prior residents of an endemic country who have since lived >=3 consecutive years in a non-endemic country and then traveled to an endemic area. PR is NOT authorized for the 3-year categories: prior residence (B.2), travel by prior residents with <3 years in a non-endemic country (B.3.a), and history of malaria (B.4). PR applies to platelets/plasma only; there is no approved device for Whole Blood or RBCs, which account for ~94% of U.S. TTM cases, so red cells from these donors still require deferral. | FDA 12/2022, transfusion-transmitted malaria guidance, §IV.B.1 & §IV.B.3.b; 21 CFR 640.120(b) | 2022-12-08 | authorized |