Rare Disease Innovation Act
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in senate (Oct 21, 2015)
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.
What just happenedOct 21, 2015
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Who’s behind it
- Introduced in SenateOct 21, 2015
- Oct 21, 2015IntroReferral
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health, Education, Labor, and Pensions Committee - Oct 21, 2015IntroReferral10000
Introduced in Senate