§ 356g. Standards for regenerative medicine and regenerative advanced therapies

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   21st Century Cures Act

   Pub. L. 114–255 div. A title III § 3036 · 130 Stat. 1033

   Enacted · 21 U.S.C. § 356g

   June 25, 1938, ch. 675, § 506G, as added Pub. L. 114–255, div. A, title III, § 3036, Dec. 13, 2016, 130 Stat. 1104

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 506G, as added Pub. L. 114–255, div. A, title III, § 3036, Dec. 13, 2016, 130 Stat. 1104

   Enacted provision · exact public law section
   SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE ADVANCED THERAPIES.   Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F the following: “SEC. 506G. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE ADVANCED THERAPIES. “(a) In General.— Not later than 2 years after the date of enactment of the 21st Century Cures Act, the Secretary, in consultation 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, regenerative medicine and advanced therapies industry organizations, and standard setting organizations), shall facilitate an effort to coordinate and prioritize the development of standards and consensus definition of terms, through a public process, to support, through regulatory predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies, including with respect to the manufacturing processes and controls of such products. “(b) Activities.— “(1) In general.— In carrying out this section, the Secretary shall continue to— “(A) identity opportunities to help advance the development of regenerative medicine therapies and regenerative advanced therapies; “(B) identify opportunities for the development of laboratory regulatory science research and documentary standards that the Secretary determines would help support the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies through regulatory predictability; and “(C) work with stakeholders, such as those described in subsection (a), as appropriate, in the development of such standards. “(2) Regulations and guidance.— Not later than 1 year after the development of standards as described in subsection (a), the Secretary shall review relevant regulations and guidance and, through a public process, update such regulations and guidance as the Secretary determines appropriate. “(c) Definitions.— For purposes of this section, the terms ‘regenerative medicine therapy’ and ‘regenerative advanced therapy’ have the meanings given such terms in section 506(g).” .

2. 2017

   FDA Reauthorization Act of 2017

   Pub. L. 115–52 title IX § 901(b) · 131 Stat. 1005

   Substituted · 21 U.S.C. § 356g(b)(1)(A)

   Pub. L. 115–52 substituted “identify” for “identity”

   Source evidence

   Code amendment note
   Subsec. (b)(1)(A). Pub. L. 115–52 substituted “identify” for “identity”.

   Enacted provision · exact public law section
   (b) Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356g(b)(1)(A)) is amended by striking “identity” and inserting “identify”.

2 of 2 references resolved to an enrolled provision