Senate Bill 3395
117th Congress(2021-2022)
Medical Device Integrity Act
Introduced
Introduced in Senate on Dec 14, 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
3395
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.
No Senate votes have been held for this bill.
Summary
Medical Device Integrity Act
This bill provides the Food and Drug Administration (FDA) with the authority to request records and information from an establishment that manufactures or otherwise prepares medical devices. Currently, the FDA only has statutory authority to make such requests to establishments that manufacture or otherwise prepare drugs.
The bill also requires the FDA to include in its requests a rationale for requesting the information in question.
December 14, 2021
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12/14/2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
12/14/2021
Introduced in Senate
Public Record
Record Updated
Dec 30, 2022 3:34:01 AM