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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
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