This guide is intended to provide the foundation of standards for clinical assessment, clinical performance, and preclinical assessment of substitutes for skin grafts.
This guide is intended to aid accurate claims and labeling for the clinical utilities of substitutes for skin grafts in regulatory reviews.
In this guide, “replacement” and “substitute” have different meanings, although they can be used synonymously in ordinary English. “Replacement” is used only as an adjective in the context of “skin replacement surgery,” which is defined in . “Substitute” is used only as a noun in the context of “skin substitute,” which is defined in 2.1.7.11.
1.1 This guide defines terminology and provides a system of classification for products that can be substituted for human or animal skin grafts (or grafts of the dermal or epidermal component tissues of skin) in medical and surgical therapies. This guide is intended to include (or be expandable to) possible future tissue engineered skin technology that could provide novel or superior therapeutic properties to those of natural skin grafts.
1.2 As much as possible, terminology is based on medical dictionary definitions.
1.3 Substitutes for skin grafts are classified by clinical utility only; the classification is independent of the technology used to make a skin substitute, its components, or whether the sources of components include human or animal tissue or other biological or non-biological materials.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.
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