S.2188: Rare Disease Innovation Act

About This Bill

  • This bill was introduced in the 114th Congress
  • This bill is primarily about health
  • Introduced Oct. 21, 2015
  • Latest Major Action Oct. 21, 2015

Bill Cosponsor

Bill Summary

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...

(Source: Library of Congress)

Bill Actions

Date Description
Oct. 21, 2015
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Oct. 21, 2015

Introduced in the Senate by Cory Gardner (R-Colo.)

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