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FDA Proposes Plan for Regulating Products Using Human Cells, Tissue

March 01, 1997| From Reuters

WASHINGTON — The Food and Drug Administration on Friday proposed a new framework for regulating medical products made from human cells or human tissue in order to safeguard against contamination, infection or other dangers.

The system would set up different "tiers" of regulation according to the degree of risk involved.

Tissue is used in skin replacement for burn victims and to repair injured tendons, ligaments, heart valves and corneas. Other tissue--semen or implanted eggs--is used in fertility treatments.

Some tissue, like that taken from a person and transplanted back into the same patient during a surgical procedure, would face little regulation.

The new system would not apply to blood banks or to organs used in donations, which are already covered by safety standards and rules about screening for such diseases as AIDS and hepatitis.

As scientists expand their ability to manipulate cells, other treatments are being explored for ailments including AIDS, Parkinson's disease and diabetes.

The FDA said the goals were to protect against accidental use of contaminated tissue that could transmit disease, to guard against improper handling that could damage or contaminate the tissue and to ensure that the product is proven to be safe and effective.

All facilities that process tissue would have to register with the FDA.

For tissue that is minimally processed and then used for its normal function, FDA oversight would be limited to proper handling and infection safeguards.

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