The Food and Drug Administration has taken another step toward implementing three rules it has proposed on the use of tissue-based products.
The first rule requires all establishments that manufacture human cells, tissues, and cellular and tissue-based products to register and list their products with the FDA. It was first proposed in 1998, and the final regulation was published in the Federal Register on January 18. HHS expects this and the other two rules - whose final regulations have not yet been published - to be finalized within two years.
"When this [first] regulation is fully implemented, it will provide, for the time, a complete base of information on the tissue bank industry, including certain cells and tissues that were not previously regulated," the Department of Health and Human Services (HHS) said in a statement. The rule covers cells and tissues including skin, tendons, bone, heart valves, and corneas and also applies to novel uses under development for human cells and tissues, such as the use of manipulated human cells to treat viral infections, Parkinson's disease, and diabetes.
One of the other two proposed rules, "Suitability Determination for Donors of Human Cellular and Tissue-Based Products," was issued on September 30, 1999, and focuses on screening and testing measures to avoid the transmission of infectious diseases. The other rule, "Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcements," was proposed on January 8 and would establish good tissue practice standards for the methods, facilities, and controls used to manufacture these products (see "New Reports and Proposed Regulations Delve Into Tissue-Based Products", Transplant News Network, January 15, 2001).
For Your Information:
HHS posts its statement at www.hhs.gov/news/press/2001pres/20010118a.html.
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