Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356g&num=0&edition=prelim
Timestamp: 2020-08-10 21:19:28
Document Index: 479641183

Matched Legal Cases: ['§ 356', '§356', '§506', '§3036', '§901', '§3034']

[USC02] 21 USC 356g: Standards for regenerative medicine and regenerative advanced therapies
<< Previous TITLE 21 / CHAPTER 9 / SUBCHAPTER V / Part A / § 356g Next >>
21 USC 356g: Standards for regenerative medicine and regenerative advanced therapies Text contains those laws in effect on August 9, 2020
§356g. Standards for regenerative medicine and regenerative advanced therapies
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.
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.
(June 25, 1938, ch. 675, §506G, as added Pub. L. 114–255, div. A, title III, §3036, Dec. 13, 2016, 130 Stat. 1104 ; amended Pub. L. 115–52, title IX, §901(b), Aug. 18, 2017, 131 Stat. 1076 .)
2017-Subsec. (b)(1)(A). Pub. L. 115–52 substituted "identify" for "identity".
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"(a) Draft Guidance.-Not later than 1 year after the date of enactment of the 21st Century Cures Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance clarifying how, in the context of regenerative advanced therapies, the Secretary will evaluate devices used in the recovery, isolation, or delivery of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."