United States Code
USC most recently checked for updates: Mar 21, 2023
A person that submits to the Secretary an application under section 360j(m) of this title, or an application (or supplement to an application) or a product development protocol under section 360e of this title, shall include in the application or protocol the information described in paragraph (2).
If the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients, the Secretary may conclude that adult data may be used to support a determination of a reasonable assurance of effectiveness in pediatric populations, as appropriate.
A study may not be needed in each pediatric subpopulation if data from one subpopulation can be extrapolated to another subpopulation.
For purposes of this section, the term “pediatric subpopulation” has the meaning given the term in section 360j(m)(6)(E)(ii) of this title.