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.
