US Congress Senate Bill 2188 (Prior Session Legislation)

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Spectrum: Bipartisan Bill
Status: Introduced on October 21 2015 - 25% progression, died in committee
Action: 2015-10-21 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]

Rare Disease Innovation Act This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals. Within 18 months of enactment of this Act, the FDA must define “probable benefit” for these devices. The FDA must report every five years on the effect of this expansion of the humanitarian device exception.

Rare Disease Innovation Act

Sen. Cory Gardner [R-CO]

Sen. Joe Donnelly [D-IN]

Date	Chamber	Action
2015-10-21	Senate	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

HB2428 (Related) 2015-05-22 - Referred to the Subcommittee on Health.
HB6 (Related) 2015-07-13 - Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/senate-bill/2188/all-info
Text	https://www.congress.gov/114/bills/s2188/BILLS-114s2188is.pdf