United States Code
USC most recently checked for updates: Sep 26, 2023
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.