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U.S.
Department of Health and Human Services
Advisory Committee on Organ Transplantation
Recommendation 50
The Advisory Committee on Organ Transplantation (ACOT) met
on May 5-6, 2008, in Rockville, MD, and unanimously agreed
on the following recommendation:
Recommendation 50: The ACOT recommends that
the Secretary take action to require accreditation of all
establishments required to be registered with the FDA as manufacturers
of human cells, tissues, and cellular- and tissue-based products
(HCT/Ps).
Such manufacturing extends to all steps in the recovery,
processing, storage, labeling, packaging, or distribution
of the HCT/P (including ocular tissues) for use in human transplantation
as well as the screening or testing of HCT/P donors. The ACOT
believes that all such establishments should be accredited,
but defers to the Secretary as to whether such accreditation
is done by the Federal Government, state governments, or non-governmental
accrediting bodies.
Pursuant to FDA regulation, "establishment" means
a place of business under one management, at one general physical
location, that engages in the manufacture of HCT/Ps. Establishment
includes (1) any individual, partnership, corporation, association,
or other legal entity engaged in the manufacture of HCT/Ps;
and (2) facilities that engage in contract manufacturing services
for a manufacturer of HCT/Ps.
The Establishment Registration form requires the establishment
to declare which of eight functions it performs: recovery,
screen, test, package, process, store, label, and distribute.
Many establishments perform more than one function.
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