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

FEDERAL · 21 U.S.C. · Chapter SUBCHAPTER V—DRUGS AND DEVICES

§360bbb–2. Classification of products

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

ChapterSUBCHAPTER V—DRUGS AND DEVICES

PartE

This text of 21 U.S.C. § §360bbb–2. Classification of products (§360bbb–2. Classification of products) is published on Counsel Stack Legal Research, covering United States primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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

Text

(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

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(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.

Source Credit

History

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

Editorial 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.

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21 U.S.C. § §360bbb–2. Classification of products, Counsel Stack Legal Research, https://law.counselstack.com/usc/21/§360bbb–2. Classification of products.