21 U.S.C. § 356g: Standards for regenerative…

Summary

The Secretary must lead a public effort, within 2 years after December 13, 2016, working with NIST and stakeholders (like manufacturers, clinical trial sponsors, contract makers, universities, clinicians, industry groups, and standards bodies) to coordinate and set priorities for standards and common terms. The goal is to make regulation more predictable for developing, testing, and reviewing regenerative medicine and regenerative advanced therapies, including their manufacturing and quality controls. The Secretary must keep finding ways to help these therapies move forward, identify needed lab research and documentary standards that would support predictable review, and work with stakeholders on those standards. Within 1 year after the standards are developed, the Secretary must review related regulations and guidance and update them through a public process as needed. Regenerative medicine therapy — defined in section 356(g). Regenerative advanced therapy — defined in section 356(g).

Title 21, §356g

Food and Drugs, Source: USLM XML via OLRC

(a)In general

Not later than 2 years after December 13, 2016, 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)identify 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 356(g) of this title.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2017—Subsec. (b)(1)(A). Pub. L. 115–52 substituted “identify” for “identity”.

Statutory Notes and Related Subsidiaries

Guidance Regarding Devices Used in the Recovery, Isolation, or Delivery of Regenerative Advanced Therapies Pub. L. 114–255, div. A, title III, § 3034, Dec. 13, 2016, 130 Stat. 1103, provided that: “(a) Draft Guidance.—Not later than 1 year after the date of enactment of the 21st Century Cures Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance clarifying how, in the context of regenerative advanced therapies, the Secretary will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies. In doing so, the Secretary shall specifically address—“(1) how the Food and Drug Administration intends to simplify and streamline regulatory requirements for combination device and cell or tissue products; “(2) what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; “(3) when the Food and Drug Administration considers it is necessary, if ever, for the intended use of a device to be limited to a specific intended use with only one particular type of cell; and “(4) application of the least burdensome approach to demonstrate how a device may be used with more than one cell type. “(b) Final Guidance.—Not later than 12 months after the close of the period for public comment on the draft guidance under subsection (a), the Secretary of Health and Human Services shall finalize such guidance.”

§356g Standards for Regenerative Medicine and Regenerative Advanced Therapies