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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.

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