2004D-0193 - DRAFT GUIDANCE FOR INDUSTRY: ELIGIBILITY DETERMINATION FOR DONORS OF HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS)
FDA Comment Number : EC1
Submitter : Ms. Deborah Greene Date & Time: 09/09/2004 11:09:52
Organization : University of Iowa Hospitals
Health Care Association
Category :
Issue Areas/Comments
GENERAL
GENERAL
Our comments are as follows:
p. 11 II F. Where are the records accompanying the HCT/P? Only when the product leaves the collecting facility? Between parts of the same facility? To the bedside? If, within the same facility, the collecting parties and the receiving parties have access to the same electronic record database containing the required information, is that sufficient to fulfill bullet 3 or does a paper record need to physically accompany the product as it travels about?

p. 22 III F. Hepatitis infection: Exclude individuals with a past diagnosis of clinical, symptomatic viral hepatitis after age 11. If the individual has documentation that the clinical, viral hepatitis was due to CMV or EBV (infectious mononucleosis) infection, these donors should not be excluded.

p. 25 III G. Please clarify whether the FDA expects to find documentation of physical examination for each of the points listed in this section, in the donor?s medical record, or whether these are truly just examples of what the exam record might look like. This is a more thorough exam than some hematopoietic stem sell/bone marrow donors are receiving at present.

p. 27 IV E. It is our understanding that bone marrow donors are also subject to this rule if the bone marrow is more than minimally manipulated. Since the recipients of these products are similar to those receiving peripheral blood hematopoietic stem/progenitor cell (HPC) transplantation, we request that testing within 30 days (as outlined in the 3rd paragraph of this section) also apply to this population of donors (rather than the 7 day rule outlined in the first paragraph of this section).

p. 32 V B. CMV testing: Since CMV does not exclude a donor from donation, it is possible that the same CMV+ individual could donate on more than one occasion. These donation could be more than 30 days apart, thus requiring this test to be repeated (along with all the other infectious disease tests), the way the guidance is currently worded. Once an individual tests positive for CMV antibody, they should always be considered positive for that test. Thus there is no need to repeat this test within 30 days of donation if the individual previously tested positive. We suggest that the wording of this section be changed to allow that, once a donor is identified as CMV positive, this test does not need to be repeated for future donations.

General comment: This guidance should be fairly straightforward to implement for US donors. However, we receive many hematopoietic stem cell/bone marrow products from international sources, because these are the best matches for our patients. Will we be able to continue to use these products when some of the donor eligibility testing has not been performed (e.g., FDA licensed tests have not been used for infectious disease testing, West Nile Virus questions/testing has not been performed, particular donor eligibility questions have not been asked)? If so, what sort of documentation will need to accompany the product?