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S. 1077, Advancing Breakthrough Devices for Patients Act of 2016 (CBO Report for Congress)

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Congress 114th
Date Requested April 5, 2016
Requested By the Senate Committee on Health, Education, Labor, and Pensions
Date Sent June 24, 2016
Description:

S. 1077 would amend the Federal Food, Drug, and Cosmetic Act to expedite the Food and Drug Administration’s (FDA’s) review of certain medical devices that represent breakthrough technologies. Such technologies include devices where no approved alternatives exist or those that offer significant advantages over existing alternatives. CBO estimates that implementing S. 1077 would cost $173 million over the 2017-2021 period, assuming appropriation of the necessary amounts. Pay-as-you-go procedures do not apply to the bill because enacting S. 1077 would not affect direct spending or revenues.

CBO estimates that enacting S. 1077 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.

S. 1077 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act and would not affect the budgets of state, local, or tribal governments.

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