0
0
0
Rare Disease Innovation Act
1/11/2023, 1:29 PM
Congressional 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.
Read the Full Bill
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, 2015
Bipartisan 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 procedures
- Congressional oversight
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Health technology, devices, supplies
Alternate Title(s) of Bill S 2188
Rare Disease Innovation Act
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the humanitarian device exemption.
Rare Disease Innovation Act
Comments
Sponsors and Cosponsors of S 2188
Latest Bills
To amend the FISA Amendments Act of 2008 to extend the authorities of title VII of the Foreign Intelligence Surveillance Act of 1978 through April 30, 2026, and for other purposes.
Bill HR 8322April 19, 2026
Space Exploration Research Act
Bill S 2351April 18, 2026
RED Tape Act
Bill HR 6398April 18, 2026
FENCES Act
Bill HR 6409April 18, 2026
A bill to extend section 702 of the Foreign Intelligence Surveillance Act of 1978 for 3 years.
Bill S 4344April 18, 2026
A bill to amend title 5, United States Code, to provide that a Member of Congress convicted of certain felony offenses relating to sexual abuse shall not be eligible for retirement benefits based on that individual's Member service, and for other purposes.
Bill S 4343April 18, 2026
SAFER Transport Act
Bill HR 8267April 18, 2026
National Wildlife Refuge System Invasive Species Strike Team Act of 2025
Bill HR 4219April 18, 2026
To amend the Marine Mammal Protection Act of 1972 to allow importation of polar bear trophies taken in sport hunts in Canada before the date the polar bear was determined to be a threatened species under the Endangered Species Act of 1973.
Bill HR 6251April 18, 2026
Western South Dakota Water Supply Project Feasibility Study Act
Bill HR 7288April 18, 2026
21st Century Cures Act
Bill HR 6January 11, 2023
21st Century Cures Act
Bill HR 34April 24, 2023
To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.
Bill HR 2428January 11, 2023