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Companies that manufacture human cells, tissues, and cellular and tissue-based products must list and register their products with the U.S. Food and Drug Administration (FDA). The regulation appeared in the Jan. 19, 2001 Federal Register. Organizations already regulated by the FDA have 105 days to comply with the rule, but new companies or those not currently regulated have two years to put the provisions into place.
The rule establishes a tiered system of oversight, and certain tissues and cells will be subject only to regulations aimed at preventing the spread of communicable disease. Other tissue-related products will be required to obtain premarket approval in addition to following the communicable disease requirements.
The new tissue rule covers a broad array of cells and tissues, such as skin, tendons, bone, heart valves, and corneas. These tissues have long been used to repair and replace damaged or diseased ones. The rule additionally applies to new uses under development for human cells and tissues, such as the use of manipulated human cells to treat viral infections, such as Parkinson’s disease and diabetes.
Tissues not previously covered under regulations now will be, such as reproductive tissues and stem cells derived from umbilical cord blood and other blood sources.