S 2205 United States Senate · 118th Congress

ISLET Act

This bill clarifies that human cadaveric islet transplants (cells from deceased donors used in diabetes treatment) are not classified as "drugs," "biological products," or "HCT/Ps" under existing federal law. It amends the Public Health Service Act to explicitly include "human cadaveric islets" in regulatory references, ensuring these transplants are not subject to the same oversight as pharmaceuticals or other biological products. The bill requires the Health Secretary to update relevant regulations within one year of enactment and report progress to Congress within six months. This change directly affects how the FDA and other agencies regulate islet transplants, streamlining their approval process without altering medical practice.
Sub-Topics: Public Health
Bill status in committee 1 of 4 stages cleared
Introduction
Jun 2023
Committee Review
Floor Vote
President
Introduced Jun 22, 2023 Last action Jun 22, 2023
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Full legislative history

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Total actions
2
Key actions
0
Committee
1
Jun 22, 2023
Committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
upper
Jun 22, 2023
Introduced
Introduced in Senate
upper
1 primary · 3 co-sponsors

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