SEC. 515A. [21 USC §360e-1] Pediatric Uses of Devices

Note: This section was added in February 2008.

(a) New devices.

(1) In general. A person that submits to the Secretary an application under section 520(m) [21 USC § 360j(m)], or an application (or supplement to an application) or a product development protocol under section 515 [21 USC § 360e], shall include in the application or protocol the information described in paragraph (2).

(2) Required information. The application or protocol described in paragraph (1) shall include, with respect to the device for which approval is sought and if readily available--

(A) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and

(B) the number of affected pediatric patients.

(3) Annual report. Not later than 18 months after the date of the enactment of this section [enacted Sept. 27, 2007], and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes--

(A) the number of devices approved in the year preceding the year in which the report is submitted, for which there is a pediatric subpopulation that suffers from the disease or condition that the device is intended to treat, diagnose, or cure;

(B) the number of devices approved in the year preceding the year in which the report is submitted, labeled for use in pediatric patients;

(C) the number of pediatric devices approved in the year preceding the year in which the report is submitted, exempted from a fee pursuant to section 738(a)(2)(B)(v) [21 USC § 379j(a)(2)(B)(v)]; and

(D) the review time for each device described in subparagraphs (A), (B), and (C).

 

(b) Determination of pediatric effectiveness based on similar course of disease or condition or similar effect of device on adults.

(1) In general. 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.

(2) Extrapolation between subpopulations. A study may not be needed in each pediatric subpopulation if data from one subpopulation can be extrapolated to another subpopulation.

 

(c) Pediatric subpopulation. For purposes of this section, the term "pediatric subpopulation" has the meaning given the term in section 520(m)(6)(E)(ii) [21 USC § 360j(m)(6)(E)(ii)].