FDA Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components
Title:
FDA Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM273685.pdf
Document Type:
Guidance for Industry
Content:
This guidance provides blood establishments that collect blood and blood components intended for transfusion or for further manufacture (referred to as "manufacturers" or "you") with advice on reporting to the Food and Drug Administration (FDA) a manufacturing change consisting of the implementation of a standardized full-length donor history questionnaire and accompanying materials (DHQ documents).