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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.

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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
1
Democrat Sponsors
0
Republican Sponsors
1
Unaffiliated Sponsors
0
Total Number of Cosponsors
0
Democrat Cosponsors
0
Republican Cosponsors
0
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 2428

Primary Policy Focus

Health

Potential 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

John Shimkus
John Shimkus
IllinoisRepublican

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