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S. 1622, FDA Device Accountability Act of 2016 1 (July 12, 2016)

handle is hein.congrec/cbo3066 and id is 1 raw text is: CONGRESSIONAL BUDGET OFFICE COST ESTIMATE July 12, 2016 S. 1622 FDA Device Accountability Act of 2016 As reported by the Senate Committee on Health, Education, Labor and Pensions on April 18, 2016 SUMMARY S. 1622 would require the Food and Drug Administration (FDA) to train certain employees to determine the least burdensome means for medical device sponsors to demonstrate the effectiveness of a device. S. 1622 would also require the agency's ombudsman to audit that training, and FDA would be required to revise guidance on addressing approaches clinical laboratories can use to demonstrate a test's accuracy. CBO estimates that implementing S. 1622 would cost $7 million over the 2017-2021 period, subject to the availability of appropriated funds. Pay-as-you-go procedures do not apply because enacting S. 1622 would not affect direct spending or revenues. CBO estimates that enacting S. 1622 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027. S. 1622 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA). ESTIMATED COST TO THE FEDERAL GOVERNMENT The estimated budgetary effect of S. 1622 is shown in the following table. The costs of this legislation fall within budget function 550 (health).

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