The recently published "Guidance for Industry: Eligibility Determination for
Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
(HCT/Ps)" finalises those requirements which had been described in a draft
guidance with the same title released in 2004. In addition, the current
document contains the measures of the Draft "Guidance for Industry:
Preventive Measures to Reduce the Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD)
by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)"
With its broad scope the guidance covers
- a comprehensive introduction explaining the activities
of FDA in this field
- donor-eligibility determination
- donor screening and
- donor testing.
Furthermore, the document features a detailed list of
literature which provides supplemental information. Examples of a flow
chart, a questionnaire, algorithms and explanations for the selection
criteria of certain relevant communicable disease agents or diseases
(RCDADs) can be found in the appendices.
The rather complex title of the guidance document should not discourage you
from reading it. With this detailed guideline you receive practice-oriented
recommendations fort implementing the requirements defined in 21 CFR part
1271, subpart C for donors of human cells and tissues.
You will find FDA's Guidance for Industry at
Dr. Ulrich Herber
On behalf of the European Compliance Academy (ECA)