To reaffirm the Safe Medical Devices Act of 1990 by requiring that the Secretary of Health and Human Services establish a schedule and issue regulations as required under section 515(i) of the Federal Food, Drug, and Cosmetic Act, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Patients Come First Act of 2011''.
SEC. 2. FINDINGS.
Congress finds as follows: (1) Under the Safe Medical Devices Act of 1990 (Public Law 101-629), Congress amended section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) to require the Food and Drug Administration to reclassify preamendment class III devices to a lower class or to require them to go through the premarket approval process. (2) The Food and Drug Administration still has not complied with the mandate of Congress under such Act, jeopardizing the health of the Nation's patients.
SEC. 3. ESTABLISHMENT OF SCHEDULE AND PROMULGATION OF REGULATION.
(a) Establishment of Schedule.--Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall establish the schedule referred to in section 515(i)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(i)(3)). (b) Regulation.--Not later than one year after the date that the schedule is established under such section 515(i)(3) (as required by subsection (a)) the Secretary shall issue a final regulation under section 515(b)...