21 U.S.C. § 356g — Standards for regenerative medicine and regenerative advanced therapies

(a) In general. Within 2 years of December 13, 2016, the Secretary — working with the National Institute of Standards and Technology and stakeholders, including regenerative medicine and advanced therapies manufacturers and clinical trial sponsors, contract manufacturers, academic institutions, practicing clinicians, industry organizations, and standard-setting organizations — must facilitate a public process to coordinate and prioritize developing standards and a consensus definition of terms. The goal is to support, through regulatory predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies, including their manufacturing processes and controls. (b) Activities. In carrying this out, the Secretary must continue to: identify opportunities to help advance the development of these therapies; identify opportunities for laboratory regulatory science research and documentary standards that would help support their development, evaluation, and review through regulatory predictability; and work with stakeholders, as described in subsection (a), on developing such standards, as appropriate. Not later than 1 year after standards under subsection (a) are developed, the Secretary must review relevant regulations and guidance and, through a public process, update them as the Secretary determines appropriate. (c) Definitions. For this section, "regenerative medicine therapy" and "regenerative advanced therapy" have the same meanings given to them in section 356(g) of this title.