FDA deferral rules (regulatory reference)
Data license: Public Domain (CDC) · Data source: CDC Travelers' Health (Yellow Fever & Malaria, by country)
7 rows
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Suggested facets: geo_scope, deferral_window, valid_from, valid_from (date)
pathogen_reduction 2
| rule_id ▼ | source_id | code | exposure_type | geo_scope | threshold | deferral_window | description | citation | valid_from | valid_to | pathogen_reduction |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FDA Transfusion-Transmitted Malaria guidance (12/2022) 2 | endemic_definition | A country/area is 'malaria-endemic' where CDC recommends antimalarial chemoprophylaxis (CDC Yellow Book / Travelers' Health) at the time the donor is screened. | FDA Guidance for Industry, Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria (final, 12/2022) | 2022-12-08 | ||||||
| 2 | FDA Transfusion-Transmitted Malaria guidance (12/2022) 2 | residence_over_5yr | residence | whole_country | continuous residence > 5 years | 3 years | A former resident (>5 continuous years) of a country that has ANY malaria-endemic area is screened treating the entire country as endemic, and is deferred 3 years (FDA 12/2022 §IV.B.2). Residence is assessed by country, not by sub-national area. The Director of CBER did NOT authorize pathogen reduction as an alternative to this deferral, citing the higher residual risk and the fact that every reported U.S. TTM case implicated former residents of endemic countries or donors with a prior malaria diagnosis. | FDA 12/2022, transfusion-transmitted malaria guidance, §IV.B.2 | 2022-12-08 | not_authorized | |
| 3 | FDA Transfusion-Transmitted Malaria guidance (12/2022) 2 | residence_reeligibility | residence | whole_country | 3 continuous years residence in a non-endemic country | 3 years | A former resident of a malaria-endemic country becomes eligible after establishing 3 continuous years of residence in a non-malaria-endemic country (with no disqualifying travel). Thereafter the donor is screened as a non-endemic resident, so subsequent endemic-area travel falls under the 3-month / pathogen-reduction travel rule (see pathogen_reduction_alternative, §IV.B.3.b). | FDA 12/2022, transfusion-transmitted malaria guidance | 2022-12-08 | ||
| 4 | FDA Transfusion-Transmitted Malaria guidance (12/2022) 2 | travel_to_endemic_area | travel | endemic_area_only | travel > 24 hours and < 5 years to a malaria-endemic area | 3 months | Travel of more than 24 hours and less than 5 years to a malaria-endemic AREA triggers assessment; the donor is assessed for such travel within the past 3 months (deferral runs 3 months from departure from the endemic area). For a resident of a non-endemic country, the Director of CBER authorized pathogen reduction as an alternative to the 3-month deferral (FDA 12/2022 §IV.B.1): platelet and/or plasma may be collected without deferral if pathogen-reduced. See pathogen_reduction_alternative. | FDA 12/2022, transfusion-transmitted malaria guidance, §IV.B.1 | 2022-12-08 | authorized | |
| 5 | FDA Transfusion-Transmitted Malaria guidance (12/2022) 2 | history_of_malaria | history | prior diagnosis of malaria | 3 years (deferral model) | A donor with a history of malaria is deferred 3 years from becoming asymptomatic while residing in a non-endemic country (FDA 12/2022 §IV.B.4). The Director of CBER did NOT authorize pathogen reduction as an alternative to this deferral. | FDA 12/2022, transfusion-transmitted malaria guidance, §IV.B.4 | 2022-12-08 | not_authorized | ||
| 6 | FDA Transfusion-Transmitted Malaria guidance (12/2022) 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 | |
| 7 | FDA Transfusion-Transmitted Malaria guidance (12/2022) 2 | testing_transition | First FDA-licensed donor malaria test (Roche cobas Malaria) approved 3/2024. A January 2025 DRAFT guidance proposes a selective-testing model that would supersede the 12/2022 deferral model; it is not yet final. Rules are versioned so the testing model can be added without redesign. | FDA cobas Malaria approval (3/2024); FDA draft guidance (Federal Register 2025-01-16) | 2024-03-01 |
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CREATE TABLE deferral_rule ( rule_id INTEGER PRIMARY KEY, source_id INTEGER REFERENCES source(source_id), code TEXT NOT NULL, exposure_type TEXT, -- 'residence' | 'travel' | 'history' geo_scope TEXT, -- 'whole_country' | 'endemic_area_only' threshold TEXT, deferral_window TEXT, description TEXT NOT NULL, citation TEXT, valid_from TEXT, valid_to TEXT , pathogen_reduction TEXT);