US Congress House Bill 2428 (Prior Session Legislation)

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Sponsorship: Partisan Bill (Republican 1)
Status: Introduced on May 19 2015 - 25% progression, died in committee
Action: 2015-05-22 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications. 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.

To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.

Rep. John Shimkus [R-IL]

Date	Chamber	Action
2015-05-22	House	Referred to the Subcommittee on Health.
2015-05-19	House	Referred to the House Committee on Energy and Commerce.
2015-05-19	House	Introduced in House

HB6 (Related) 2015-07-13 - Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
SB2188 (Related) 2015-10-21 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/house-bill/2428/all-info
Text	https://www.congress.gov/114/bills/hr2428/BILLS-114hr2428ih.pdf