Rare Disease Innovation Act
1/11/2023, 1:29 PMCongressional Summary of S 2188
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.
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Current Status of Bill S 2188
Bill S 2188 is currently in the status of Bill Introduced since October 21, 2015. Bill S 2188 was introduced during Congress 114 and was introduced to the Senate on October 21, 2015. Bill S 2188's most recent activity was Read twice and referred to the Committee on Health, Education, Labor, and Pensions. as of October 21, 2015Bipartisan Support of Bill S 2188
Total Number of Sponsors
1Democrat Sponsors
0Republican Sponsors
1Unaffiliated Sponsors
0Total Number of Cosponsors
1Democrat Cosponsors
1Republican Cosponsors
0Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill S 2188
Primary Policy Focus
HealthPotential Impact Areas
Administrative law and regulatory proceduresCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationHealth technology, devices, suppliesAlternate Title(s) of Bill S 2188
Rare Disease Innovation ActA bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the humanitarian device exemption.Rare Disease Innovation ActComments
Most relevant
Sponsors and Cosponsors of S 2188
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