---
kind: "section"
citation: "21 U.S.C. § 356k"
title: "21"
title_heading: "Food and Drugs"
number: "356k"
heading: "Platform technologies"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/356k"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §356k. Platform technologies

- (a) **In general—** The [Secretary](/usc/21/321.md?p=d) shall establish a program for the designation of platform technologies that meet the criteria described in [subsection (b)](#b).
- (b) **Criteria—** A platform technology incorporated within or utilized by a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) is eligible for designation as a designated platform technology under this section if—
  - (1) the platform technology is incorporated in, or utilized by, a [drug](/usc/21/321.md?p=g-1) approved under [section 355 of this title](/usc/21/355.md) or a biological [product](/usc/21/360eee.md?p=13) [licensed](/usc/21/360eee.md?p=9) under section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)];
  - (2) preliminary evidence submitted by the [sponsor](/usc/21/360fff.md?p=8) of the approved or [licensed](/usc/21/360eee.md?p=9) [drug](/usc/21/321.md?p=g-1) described in [paragraph (1)](#b-1), or a [sponsor](/usc/21/360fff.md?p=8) that has been granted a right of reference to data submitted in the application for such [drug](/usc/21/321.md?p=g-1), demonstrates that the platform technology has the potential to be incorporated in, or utilized by, more than one [drug](/usc/21/321.md?p=g-1) without an adverse effect on quality, manufacturing, or safety; and
  - (3) data or information submitted by the applicable [person](/usc/21/321.md?p=e) under [paragraph (2)](#b-2) indicates that incorporation or utilization of the platform technology has a reasonable likelihood to bring significant efficiencies to the [drug](/usc/21/321.md?p=g-1) development or manufacturing process and to the review process.
- (c) **Request for designation—** A [person](/usc/21/321.md?p=e) may request the [Secretary](/usc/21/321.md?p=d) designate a platform technology as a designated platform technology concurrently with, or at any time after, submission under [section 355(i) of this title](/usc/21/355.md?p=i) or section 351(a)(3) of the Public Health Service Act [[42 U.S.C. 262(a)(3)](/usc/42/262.md?p=a-3)] for the investigation of a [drug](/usc/21/321.md?p=g-1) that incorporates or utilizes the platform technology that is the subject of the request.
- (d) **Designation—**
  - (1) **In general—** Not later than 90 calendar days after the receipt of a request under [subsection (c)](#c), the [Secretary](/usc/21/321.md?p=d) shall determine whether the platform technology that is the subject of the request meets the criteria described in [subsection (b)](#b).
  - (2) **Designation—** If the [Secretary](/usc/21/321.md?p=d) determines that the platform technology meets the criteria described in [subsection (b)](#b), the [Secretary](/usc/21/321.md?p=d) shall designate the platform technology as a designated platform technology and may expedite the development and review of any subsequent application submitted under [section 355(b) of this title](/usc/21/355.md?p=b) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](/usc/42/262.md?p=a)] for a [drug](/usc/21/321.md?p=g-1) that uses or incorporates the platform technology pursuant to [subsection (e)](#e), as appropriate.
  - (3) **Determination not to designate—** If the [Secretary](/usc/21/321.md?p=d) determines that the platform technology does not meet the criteria under [subsection (b)](#b), the [Secretary](/usc/21/321.md?p=d) shall include with the determination not to designate the technology a written description of the rationale for such determination.
  - (4) **Revocation of designation—** The [Secretary](/usc/21/321.md?p=d) may revoke a designation made under [paragraph (2)](#d-2), if the [Secretary](/usc/21/321.md?p=d) determines that the designated platform technology no longer meets the criteria described in [subsection (b)](#b). The [Secretary](/usc/21/321.md?p=d) shall communicate the determination to revoke a designation to the requesting [sponsor](/usc/21/360fff.md?p=8) in writing, including a description of the rationale for such determination.
  - (5) **Applicability—** Nothing in this section shall prevent a [product](/usc/21/360eee.md?p=13) that uses or incorporates a designated platform technology from being eligible for expedited approval pathways if it is otherwise eligible under this chapter or the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.].
- (e) **Actions—** The [Secretary](/usc/21/321.md?p=d) may take actions to expedite the development and review of an application for a [drug](/usc/21/321.md?p=g-1) that incorporates or utilizes a designated platform technology, including—
  - (1) engaging in early interactions with the [sponsor](/usc/21/360fff.md?p=8) to discuss the use of the designated platform technology and what is known about such technology, including data previously submitted that is relevant to establishing, as applicable, safety or efficacy under [section 355(b) of this title](/usc/21/355.md?p=b) or safety, purity, or potency under section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](/usc/42/262.md?p=a)];
  - (2) providing timely advice to, and interactive communication with, the [sponsor](/usc/21/360fff.md?p=8) regarding the development of the [drug](/usc/21/321.md?p=g-1) that proposes to use the designated platform technology to ensure that the development program designed to gather data necessary for approval or licensure is as efficient as practicable, which may include holding meetings with the [sponsor](/usc/21/360fff.md?p=8) and the review team throughout the development of the [drug](/usc/21/321.md?p=g-1); and
  - (3) considering inspectional findings, including prior findings, related to the manufacture of a [drug](/usc/21/321.md?p=g-1) that incorporates or utilizes the designated platform technology.
- (f) **Leveraging data from designated platform technologies—** The [Secretary](/usc/21/321.md?p=d) shall, consistent with applicable standards for approval, authorization, or licensure under this chapter and section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](/usc/42/262.md?p=a)], allow the [sponsor](/usc/21/360fff.md?p=8) of an application under [section 355(b) of this title](/usc/21/355.md?p=b) or section 351(a) of the Public Health Service Act or a request for emergency use authorization under [section 360bbb–3 of this title](/usc/21/360bbb–3.md), in order to support approval, licensure, or authorization, to reference or rely upon data and information within an application or request for a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) that incorporates or utilizes the same platform technology designated under [subsection (d)](#d), provided that—
  - (1) such data and information was submitted by the same [sponsor](/usc/21/360fff.md?p=8), pursuant to the application for the [drug](/usc/21/321.md?p=g-1) with respect to which designation of the designated platform technology under [subsection (d)](#d) was granted; or
  - (2) the [sponsor](/usc/21/360fff.md?p=8) relying on such data and information received a right of reference to such data and information from the [sponsor](/usc/21/360fff.md?p=8) described in [paragraph (1)](#f-1).
- (g) **Changes to a designated platform technology—** A [sponsor](/usc/21/360fff.md?p=8) of more than one application approved under [section 355(b) of this title](/usc/21/355.md?p=b) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](/usc/42/262.md?p=a)] for [drugs](/usc/21/321.md?p=g-1) that incorporate or utilize a designated platform technology may submit a single supplemental application for proposed changes to the designated platform technology that may be applicable to more than one such [drug](/usc/21/321.md?p=g-1) that incorporates or utilizes the same designated platform technology. Such supplemental application may cross-reference data and information submitted in other applications and may include one or more comparability protocols regarding how such changes to the platform technology would be made for each applicable [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13).
- (h) **Definitions—** For purposes of this section:
  - (1) The term “platform technology” means a well-understood and reproducible technology, which may include a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, or a combination of any such technologies that the [Secretary](/usc/21/321.md?p=d) determines to be appropriate, that the [sponsor](/usc/21/360fff.md?p=8) demonstrates—
    - (A) is incorporated in or utilized by a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) and is essential to the structure or function of such [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13);
    - (B) can be adapted for, incorporated into, or utilized by, more than one [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) sharing common structural elements; and
    - (C) facilitates the manufacture or development of more than one [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) through a standardized production or manufacturing process or processes.
  - (2) The term “designated platform technology” means a platform technology that is designated as a platform technology under [subsection (d)](#d).
- (i) **Rule of construction—** Nothing in this section shall be construed to—
  - (1) alter the authority of the [Secretary](/usc/21/321.md?p=d) to approve [drugs](/usc/21/321.md?p=g-1) pursuant to section 505 of this Act [[21 U.S.C. 355](/usc/21/355.md)] or license biological [products](/usc/21/360eee.md?p=13) pursuant to section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)], including standards of evidence and applicable conditions for approval or licensure under the applicable Act; or
  - (2) confer any new rights with respect to the permissibility of a [sponsor](/usc/21/360fff.md?p=8) of an application for a [drug product](/usc/21/321.md?p=dd) or biological [product](/usc/21/360eee.md?p=13) referencing information contained in another application submitted by the holder of an approved application under [section 355(c) of this title](/usc/21/355.md?p=c) or of a license under section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](/usc/42/262.md?p=a)].

## Source credit

(June 25, 1938, ch. 675, § 506K, as added Pub. L. 117–328, div. FF, title II, § 2503(a), Dec. 29, 2022, 136 Stat. 5798.)

## Notes

### Editorial Notes

### References in Text

The Public Health Service Act, referred to in subsec. (d)(5), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

### Statutory Notes and Related Subsidiaries

### Guidance

Pub. L. 117–328, div. FF, title II, § 2503(b), Dec. 29, 2022, 136 Stat. 5801, provided that: “Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall issue draft guidance on the implementation of this section. Such guidance shall include examples of drugs that can be manufactured using platform technologies, including drugs that contain or consist of vectors and nucleic acids, information about the Secretary’s review of platform technologies, information regarding submitting for designation, considerations for persons submitting a request for designation who have been granted a right of reference, the implementation of the designated platform technology designation program, efficiencies that may be achieved in the development and review of products that incorporate or utilize designated platform technologies, and recommendations and requirements for making and reporting manufacturing changes to a designated platform technology in accordance with section 506K(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356k(g)] (as added by subsection (a)) and section 506A of such Act (21 U.S.C. 356a), as applicable.”