Ebola Virus: New FDA Guidance For Blood Collection.
Legal Eagle Eye Newsletter for the Nursing Profession
February 2017
On January 10, 2017 the US Food and Drug Administration (FDA) announced the availability of a new document titled Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry.
We have this new guidance document on our website at http://www.nursinglaw.com/FDA011017.pdf
This document and FDA guidance documents on a wide variety of subjects are available directly from the FDA’s website at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
This and other FDA guidance documents make it clear that they only reflect the FDA’s current scientific thinking on a particular subject and do not create mandatory legal requirements or confer legal rights.
FEDERAL REGISTER January 10, 2017 Pages 3002 - 3004