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RCP Congressional Bill Tracker - H.R. 2428

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H.R. 2428: To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.

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

Introduced: May 19, 2015 (114th Congress)

Sponsor: (No First Name Found) (No Last Name Found) [-]

Status: Referred to Committee - Referred to the Subcommittee on Health.

Summary: 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.

Votes


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