U.S. Code
- Title 1 General Provisions
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- Title 4 Flag and Seal, Seat Of Government,and the States
- Title 5 Government Organization and Employees
- Appendix to Title 5
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- Appendix to Title 10 (Rules of Court of Appeals for the Armed Forces)
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- Appendix to Title 11
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- Appendix to Title 38 (Rules of Court of Appeals for Veterans Claims()
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- Appendix to Title 50
§ 360bbb-2. Classification of products
(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) of this section, the Secretary shall determine the classification of the product under subsection (a) of this section, 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) of this section, the recommendation made by the person under subsection (a) of this section 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.
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