S. 1101 would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to exempt certain medical software from regulation as a medical device and, as a result, from an excise tax on such devices. Because enacting the bill would affect revenues, pay-as-you-go procedures apply. However, CBO and the Joint Committee on Taxation (JCT) estimate that those losses would be less than $500,000 over the 2017-2026 period. Enacting the legislation would not affect direct spending.
S. 1101 also would direct the Secretary of Health and Human Services (HHS) to classify and regulate accessories to medical devices separately from the device they operate. In addition, the legislation would require preparation of a report on the risks and benefits of using medical software. CBO estimates that implementing the legislation would cost the Food and Drug Administration (FDA) $60 million over the 2017-2021 period, assuming appropriation of the necessary amounts.
CBO estimates that enacting S. 1101 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.
S. 1101 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act.
