BK261333- Blood Product Questionnaire Module (v2.0.0)
The FDA has released or updated the Blood Product Questionnaire Module (v2.0.0), designed to assist blood establishment collection facilities in managing donor history questionnaires and determining donor eligibility and unit suitability.
This update affects single and multi-site blood establishment collection facilities and internal departments responsible for donor screening and blood product quality control.
The release of a specific module version suggests an effort to standardize the digital or procedural tools used for donor screening across blood collection sites. This may impact how facilities capture donor history and automate the determination of eligibility, potentially streamlining compliance with safety requirements. Regulatory teams should consider how this versioning affects their validated systems for maintaining the safety and suitability of the blood supply.
Regulatory and QA teams should review the updated module (v2.0.0) functionality against existing donor history platforms to ensure alignment with current eligibility and suitability logic. IT and compliance departments should plan for validation and integration of this module if utilized for determining donor eligibility.
The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities’ creation of a donor history questionnaire, the collection of donor history, the determination of visit requirements, the determination of donor eligibility, and unit suitability.
Open in openFDA / FDA.gov