21 U.S.C. § 360bbb–2: Classification of products

Summary

You can ask the Secretary to decide whether a product is a drug, biological product, device, or a combination product covered by section 353(g), or to say which FDA part will regulate it. When you ask, you must say which classification or FDA component you think is right. The Secretary must send a written answer with the decision and reasons within 60 days. The Secretary can only change that answer if you agree in writing or if new scientific evidence shows a public health need. If no answer is given in 60 days, your recommendation becomes final and can only be changed the same two ways.

Title 21, §360bbb–2

Food and Drugs, Source: USLM XML via OLRC

(a)Request

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)Statement

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)Inaction of Secretary

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.

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.

§360bbb–2 Classification of Products

Summary

Title 21, §360bbb–2

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Effective Date

Citations & Metadata