(1) In general 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).
(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 September 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
379j (a)(2)(B)(v) of this title; and
(D) the review time for each device described in subparagraphs (A), (B), and (C).
