TABLE 4-1 Current FDA Regulation of Organs, Tissues, and Cells

 

Unmanipulated

Manipulated

Nonliving

Source

Allo organs

Allo cells/tissues

Xeno organs

Allo cells/tissues

Auto cells/tissues

Encapsulated cells/tissues

Transgenic cells/tissues

Antibody-treated cells/tissues

Pig heart valve

Artificial heart

Premarket approval

Nonea

Nonea

Nonea

Biologic

Biologic

Biologic

Biologic

Biologic

Deviceb

Device

a Infectious disease and other requirements apply, but there is no requirement for premarket approval. Xenogeneic organs may be subject to Section 361 of the Public Health Service Act, according to proposals. This section provides authority to issue regulations to control communicable diseases.

b Pretreated with glutaraldehyde or another agent that sterilizes or "fixes" the issue.

SOURCE: FDA (1993) and Kessler et al. (1993).



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