Political Quotes

“I have an amendment at the desk. The Acting CHAIR. The Clerk will designate the amendment. The text of the amendment is as follows: Page 235, insert after line 2 the following new subtitle: Subtitle R--Other Provisions SEC. 2321. STUDY ON TWO-TIERED APPROVAL PROCESS FOR DEVICES BY FDA. (a) In General.--Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report assessing the feasibility, benefits, and risks associated with establishing an expedited, two-tiered approval process for devices (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) that would enable devices to be lawfully marketed as of the date on which the device has been shown to be safe-- (1) regardless of whether the device has been shown to be effective; and (2) so long as the person submitting the application for approval of the device has made no false claims with respect to whether the device is safe or effective.…”