regenerative medicine therapy
Defined in 2 places of the United States Code.
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 [42 U.S.C. 264] and part 1271 of title 21, Code of Federal Regulations.
Source
- 2016–present21 U.S.C. § 356Food and Drugs · Fast track products · for purposes of this section
For purposes of this section, the terms “regenerative medicine therapy” and “regenerative advanced therapy” have the meanings given such terms in section 356(g) of this title.
Source
- 2016–present21 U.S.C. § 356gFood and Drugs · Standards for regenerative medicine and regenerative advanced therapies · for purposes of this section