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(21 CFR Part 1270) Human tissue intended for transplantation that is recovered, processed, stored or distributed by methods that do not change tissue function or characteristics and that is not currently regulated as a human drug, biological product, or medical device. Examples of such tissues are bone, skin. Corneas, ligament, and tendon.
Publication Source: ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products
Publication Date: 2007
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