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UsFDA Guidance: Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to an Ebola Disease Outbreak
Maintaining the safety of the blood supply is a critical public health priority, particularly during outbreaks of emerging infectious diseases. Ebola disease, caused by viruses of the Orthoebolavirus genus, is associated with severe illness and can be transmitted through direct contact with infected body fluids. Although transfusion-transmitted Ebola disease has not been widely documented, the potential risk of transmission through blood and blood components requires appropri
Sharan Murugan
Jul 23 min read
USFDA Guidance: Artificial Intelligence-Enabled Device Software Functions – Lifecycle Management and Marketing Submission Recommendations
The U.S. Food and Drug Administration (FDA) has issued a draft guidance document titled “ Artificial Intelligence-Enabled Device Software...
Sharan Murugan
Jan 7, 20252 min read