REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.

SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.(a) In General.—The Comptroller General of the United States shall conduct a study on the appropriate use of the process under section 510(k) of the Federal Food, Drug, and Cosmetic Act as part of the device classification process to determine whether a new device is as safe and effective as a classified device.(b) Consideration.—In determining the effectiveness of the premarket notification and classification authority under section 510(k) and subsections (f) and (i) of section 513 of the Federal Food, Drug, and Cosmetic Act, the study under subsection (a) shall consider the Secretary of Health and Human Services’s evaluation of the respective intended uses and technologies of such devices, including the effectiveness of such Secretary’s comparative assessment of technological characteristics such as device materials, principles of operations, and power sources.(c) Report.—Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall complete the study under subsection (a) and submit to the Congress a report on the results of such study.