Bill114th CongressFiled May 19, 2015Health
H.R. 2428
To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.
Bill journey · stage 2 of 5
Under committee review
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What it doesSummary introduced in house (May 19, 2015)
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.What just happenedMay 22, 2015
Referred to the Subcommittee on Health.
Who’s behind it
Rep. Shimkus, John [R-IL-15](R-IL)Sponsor
1committees4actions3related bills4subjects
- Introduced in HouseMay 19, 2015
- May 22, 2015Committee
Referred to the Subcommittee on Health.
Health Subcommittee - May 19, 2015IntroReferralH11100
Referred to the House Committee on Energy and Commerce.
Energy and Commerce Committee - May 19, 2015IntroReferralIntro-H
Introduced in House
- May 19, 2015IntroReferral1000
Introduced in House