---
kind: "section"
citation: "21 U.S.C. § 360bbb–2"
title: "21"
title_heading: "Food and Drugs"
number: "360bbb–2"
heading: "Classification of products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bbb-2"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part E — General Provisions Relating to Drugs and Devices"
---

# §360bbb–2. Classification of products

- (a) **Request—** A [person](/usc/21/321.md?p=e) who submits an application or submission (including a petition, notification, and any other similar form of request) under this chapter for a [product](/usc/21/360eee.md?p=13), may submit a request to the [Secretary](/usc/21/321.md?p=d) respecting the classification of the [product](/usc/21/360eee.md?p=13) as a [drug](/usc/21/321.md?p=g-1), biological [product](/usc/21/360eee.md?p=13), [device](/usc/21/321.md?p=h-1), or a combination [product](/usc/21/360eee.md?p=13) subject to [section 353(g) of this title](/usc/21/353.md?p=g) or respecting the component of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration that will regulate the [product](/usc/21/360eee.md?p=13). In submitting the request, the [person](/usc/21/321.md?p=e) shall recommend a classification for the [product](/usc/21/360eee.md?p=13), or a component to regulate the [product](/usc/21/360eee.md?p=13), as appropriate.
- (b) **Statement—** Not later than 60 days after the receipt of the request described in [subsection (a)](#a), the [Secretary](/usc/21/321.md?p=d) shall determine the classification of the [product](/usc/21/360eee.md?p=13) under [subsection (a)](#a), or the component of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration that will regulate the [product](/usc/21/360eee.md?p=13), and shall provide to the [person](/usc/21/321.md?p=e) a written statement that identifies such classification or such component, and the reasons for such determination. The [Secretary](/usc/21/321.md?p=d) may not modify such statement except with the written consent of the [person](/usc/21/321.md?p=e), or for public health reasons based on scientific evidence.
- (c) **Inaction of Secretary—** If the [Secretary](/usc/21/321.md?p=d) does not provide the statement within the 60-day period described in [subsection (b)](#b), the recommendation made by the [person](/usc/21/321.md?p=e) under [subsection (a)](#a) shall be considered to be a final determination by the [Secretary](/usc/21/321.md?p=d) of such classification of the [product](/usc/21/360eee.md?p=13), or the component of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration that will regulate the [product](/usc/21/360eee.md?p=13), as applicable, and may not be modified by the [Secretary](/usc/21/321.md?p=d) except with the written consent of the [person](/usc/21/321.md?p=e), or for public health reasons based on scientific evidence.

## Source credit

(June 25, 1938, ch. 675, § 563, as added Pub. L. 105–115, title IV, § 416, Nov. 21, 1997, 111 Stat. 2378.)

## Notes

### Statutory Notes and Related Subsidiaries

### Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.