regenerative medicine therapy

(8)For purposes of this section, the term “regenerative medicine therapy” includes cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act [] andCode of Federal Regulations. (h)


21 USC § 356(g)(8)

Scoping language

For purposes of this section
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