0
0
0
To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.
1/11/2023, 1:31 PM
Congressional Summary of HR 2428
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.Read the Full Bill
Current Status of Bill HR 2428
Bill HR 2428 is currently in the status of Bill Introduced since May 19, 2015. Bill HR 2428 was introduced during Congress 114 and was introduced to the House on May 19, 2015. Bill HR 2428's most recent activity was Referred to the Subcommittee on Health. as of May 22, 2015
Bipartisan Support of Bill HR 2428
Total Number of Sponsors
1Democrat Sponsors
0Republican Sponsors
1Unaffiliated Sponsors
0Total Number of Cosponsors
0Democrat Cosponsors
0Republican Cosponsors
0Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 2428
Primary Policy Focus
HealthPotential Impact Areas
- Administrative law and regulatory procedures
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Health technology, devices, supplies
Alternate Title(s) of Bill HR 2428
To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.
To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.
Comments
Sponsors and Cosponsors of HR 2428
Latest Bills
Ending Importation of Russian Oil Act
Bill HR 6968March 11, 2026
Housing for the 21st Century Act
Bill HR 6644March 11, 2026
WORK to Save Lives Act
Bill S 3812March 11, 2026
Living Donor Protection Act of 2025
Bill S 1552March 11, 2026
SAVES Act of 2025
Bill S 1441March 11, 2026
HONOR Act
Bill S 327March 11, 2026
Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes.
Bill HR 7147March 11, 2026
A bill to prohibit the Department of Homeland Security from constructing, acquiring, renovating, or operating any new processing site or detention center without providing a mechanism for public comments regarding such activity, entering into a signed, written agreement with appropriate State and local officials, and providing Congress with advance notice of such activity.
Bill S 3894March 11, 2026
A bill to amend title 10, United States Code, to authorize representatives of veterans service organizations to participate in presentations to promote certain benefits available to veterans during preseparation counseling under the Transition Assistance Program of the Department of Defense, and for other purposes.
Bill S 3938March 11, 2026
A bill to amend the Elementary and Secondary Education Act of 1965 to expand access to school-wide arts and music programs, and for other purposes.
Bill S 4018March 11, 2026
Rare Disease Innovation Act
Bill S 2188January 11, 2023
21st Century Cures Act
Bill HR 6January 11, 2023
21st Century Cures Act
Bill HR 34April 24, 2023