Bill Sponsor
Senate Bill 1508
117th Congress(2021-2022)
A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes.
Introduced
Introduced
Introduced in Senate on Apr 29, 2021
Overview
Text
Introduced
Apr 29, 2021
Latest Action
Apr 29, 2021
Origin Chamber
Senate
Type
Bill
Bill
The primary form of legislative measure used to propose law. Depending on the chamber of origin, bills begin with a designation of either H.R. or S. Joint resolution is another form of legislative measure used to propose law.
Bill Number
1508
Congress
117
Policy Area
Health
Health
Primary focus of measure is science or practice of the diagnosis, treatment, and prevention of disease; health services administration and funding, including such programs as Medicare and Medicaid; health personnel and medical education; drug use and safety; health care coverage and insurance; health facilities. Measures concerning controlled substances and drug trafficking may fall under Crime and Law Enforcement policy area.
Sponsorship by Party
Republican
Kansas
Republican
Louisiana
Democrat
Minnesota
Senate Votes (0)
House Votes (0)
No Senate votes have been held for this bill.
Summary

This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product.

Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval.

Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.

Text (1)
April 29, 2021
Actions (2)
04/29/2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
04/29/2021
Introduced in Senate
Public Record
Record Updated
Jan 11, 2023 1:49:03 PM