CFR section

21 CFR 630.5(b): Medical supervision

PART 630-REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE · Subpart B-Donor Eligibility Requirements

Key facts

Citation 21 CFR 630.5(b)
Section Medical supervision
Part PART 630-REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE
Subpart Subpart B-Donor Eligibility Requirements
Subchapter 21 CFR F Biologics
Product types cited Biologics
Regulation text (excerpt) (b) Which activities related to the collection of blood and blood components, other than Source Plasma and plasma collected by plasmapheresis, may the responsible physician delegate ? (1) The responsible physician may delegate the following activities to a physician substitute or other trained person: (i) Determining the eligibility of a donor and documenting assessments related to that determination, except the responsible physician must not delegate: (A) The examination and determination of…

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