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Title 21, Food and DrugsRelease 119-73not60

§360bbb–2 Classification of Products

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices › § 360bbb–2

Last updated Apr 5, 2026|Official source

Summary

Anyone who applies to the FDA for a product can ask the Secretary to decide whether the product is a drug, a biological product, a device, or a combination product under section 353(g), and can ask which FDA office will regulate it. The applicant must say which classification they think fits. The Secretary must answer in writing within 60 days and explain the choice. If no written reply comes in 60 days, the applicant’s choice becomes final. The Secretary can only change that decision with the applicant’s written consent or for public health reasons based on scientific evidence.

Full Legal Text

Title 21, §360bbb–2

Food and Drugs, Source: USLM XML via OLRC

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

Legislative History

Notes & Related Subsidiaries

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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 360bbb–2

Title 21, Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60