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Advisory Committee on Organ Transplantation

U.S. Department of Health and Human Services

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.